MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-13 for OUTER RAIL FOR PELVIC C-CLAMP II 03.306.001 manufactured by Synthes Bettlach.
[69763386]
(b)(4). Device is an instrument and is not implanted/explanted. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. (b)(6). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. 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
[69763387]
Device report from synthes (b)(4) reports an event in (b)(6) as follow: it was reported that the bolts of sliding mechanism of two outer rails and one upper side arm were broken. The issue was detected at cleaning and sterilization department post-operative. It is unknown when the breakage occurred. No impact related to patient or surgery was reported. This report is for one (1) outer rail for pelvic c-clamp ii. This is report 2 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[73007482]
A device history record review was not performed for the subject device lot number 252038 since article & lot number do not match therefore not able to review dhr. Manufacture date is unknown. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[75637115]
Device was used for treatment, not diagnosis. A product development investigation was performed for the subject device (outer rail for pelvic c-clamp ii, part number 03. 306. 001, lot number 2520381). The subject device was returned with the complaint condition stating: received parts: one x 03. 306. 001 / outer rail f/pelvic c-clamp / lot number 2520381, one x 03. 306. 001 / outer rail f/pelvic c-clamp / lot number 2521269, one x 03. 306. 002 / upper side arm f/pelvic c-clamp / lot number 2518336. The 03. 306. 001: there are marks and scratches visible on the outer rail's surface of both parts. Furthermore, we have found that the locking bolts are missing. The 03. 306. 002: upper side arm have normal wear and tear signs. Furthermore, we have found that the locking bolt is missing. We received only two locking bolts halves. The other parts are missing. Conclusion: our investigation shows, that the received parts have normal wear and tear signs besides some marks visible on the surfaces. Furthermore, we have found that both outer rail parts and the upper side arm, the locking bolts are missing. The lots in question were manufactured in september - october 2009 and we are not aware of any product quality related issues. Unfortunately, we only have limited information in the complaint description and cannot confirm how this happened. Based on wear and tear signs on the received parts, which are most likely referable by use over the years, we are not able to define where exactly and at which point the parts got lost. A 100% functional check guaranteed the functionality and the completeness of all instruments when left our facility. We are not aware of any quality problems or failures caused by a faulty product on the articles. Therefore, we conclude that the cause of failure is not due to any manufacturing non-conformances. 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 | 2520274-2017-10832 |
| MDR Report Key | 6398771 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-13 |
| Date of Report | 2017-02-20 |
| Date Mfgr Received | 2017-05-02 |
| Date Added to Maude | 2017-03-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| 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 | OUTER RAIL FOR PELVIC C-CLAMP II |
| Generic Name | TRACTION,COMPONENT,INVASIVE |
| Product Code | JEC |
| Date Received | 2017-03-13 |
| Returned To Mfg | 2017-04-06 |
| Catalog Number | 03.306.001 |
| Lot Number | 2520381 |
| Operator | PHYSICIAN |
| 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 | 2017-03-13 |