MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-16 for UPPER SIDE ARM FOR PELVIC C-CLAMP II 03.306.002 manufactured by Synthes Bettlach.
[40785160]
Device is an instrument and is not implanted/explanted. The lot number provided could not be verified, without a valid lot number the device history records review could not be completed. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[40785161]
It was reported while using the upper side arm for pelvic c-clamp ii during a pelvic surgery where sacroiliac screws were being implanted, it was noted that one of the locking pins was missing from one of the pelvic c-clamp arms. The surgery was completed without any surgical delays as the device was still operable and still held on as expected without the pin. There was no impact to the surgery or to the patient. There was no additional medical intervention required and no surgical delays. The patient was noted to be stable at the end of surgery. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[41963475]
Device was used for treatment, not diagnosis. Clarification: the reported lot number, 2694705, was able to be verified. A device history record review was performed for the subject device lot. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. As previously reported, the subject device has been received and is currently in the evaluation process. Synthes manufacturing location was corrected. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[41963476]
Additional information was received on march 20, 2016. It was further reported that half of the locking pin was found in the device and the other half of the locking pin was found in the graphics case prior to use on the patient. There were no fragments or pins retained in the patient. The date of the reported surgical procedure was (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[44910967]
A product investigation was completed: per the technique guide, the 03. 306. 002 upper side arm for pelvic c-clamp ii is an instrument routinely used in the pelvic c-clamp ii system along with the 03. 306. 000 inner rail for pelvic c-clamp ii, 03. 306. 001 outer rail for pelvic c-clamp ii for emergency stabilization for unstable injuries and fractures of the pelvic ring. The 03. 306. 002 upper side arm was returned and reported to be missing a pin from the locking mechanism area. This condition is confirmed; the pin/ sliding portion of the locking mechanism was not returned for the device. It is likely that the pin component was lost during sterile processing leading to this complaint condition. The 03. 306. 002 upper side arm was manufactured in february 2011 and is over 5 years old. The device is in fairly worn condition with several scrape and scuff marks along its length. The relevant drawings for the entire 03. 306. 010 assembly and upper arm were reviewed during this evaluation. The locking mechanism pin is pressed into place to secure. The design is determined to be suitable for the intended design, application and dimensional conformity when used as recommended. The condition of the returned 03. 306. 002 upper side arm does agree with the complaint description. Unable to determine a definitive root cause. It is likely that the pin component was lost during sterile processing leading to this complaint condition. The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2016-11675 |
| MDR Report Key | 5504782 |
| Date Received | 2016-03-16 |
| Date of Report | 2016-02-29 |
| Date of Event | 2016-02-29 |
| Date Mfgr Received | 2016-04-15 |
| Device Manufacturer Date | 2011-02-04 |
| Date Added to Maude | 2016-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES BETTLACH |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CH2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UPPER SIDE ARM FOR PELVIC C-CLAMP II |
| Generic Name | TRACTION, COMPONENT, INVASIVE |
| Product Code | JEC |
| Date Received | 2016-03-16 |
| Returned To Mfg | 2016-03-10 |
| Catalog Number | 03.306.002 |
| Lot Number | 2694705 |
| ID Number | (01)10886982077691(10)2694705 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH PA CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-16 |