MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-06-22 for TREPHINE ATTACHMENT 5.5MM DIAMETER 03.111.025 manufactured by Synthes Bettlach.
[22158323]
Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that pieces of trephine broken during surgery, fragment is not in patient. Delayed surgery by 1 hour. Surgeon used instrument according to surgical technique. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[22330576]
Device was used for treatment, not diagnosis. Additional narrative: patient information not provided by reporter. Device is an instrument and is not implanted/explanted. Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[27159251]
Device history records was conducted. The report indicates that the: manufacturing site: (b)(4). Manufacturing date: 11. May 2012. No ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. A manufacturing investigation summary was conducted. The report indicates that: no product fault could be detected. The lot in question was manufactured with a lot size of (b)(4) pieces in may 2012 and we are not aware of any other complaint for this article- and lot number. Based on the provided information we are not able to determine the exact cause of this occurrence and can only assume that a mechanical overload did lead to the breakage. We found that the corners of the intact teeth are slightly rounded and blunt, but afterwards it cannot be defined if this was caused be wear and tear or a metallic contact. The examination of the manufacturing papers showed no deviations regarding, dimensions, harness, material analysis, strength and structural stability. The values were in compliance with ao/asif specification and with the international standard 1. 4112 stainless steel. The fracture face is homogenous, which indicates material conformity. 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
[27321607]
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
[27371243]
(b)(4). 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
[27371244]
Device report from (b)(4) reports an event in (b)(6). Additional information was provided that: during surgery the bone trephine was being used to harvest bone graft when the rn noticed that part of the trephine had broken off. No injury to the patient or healthcare staff. The patient was x-rayed at the time of the incident which was showed that no abnormalities were detected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2015-14580 |
| MDR Report Key | 4860465 |
| Report Source | 01,05,07 |
| Date Received | 2015-06-22 |
| Date of Report | 2015-06-08 |
| Date of Event | 2015-06-08 |
| Date Mfgr Received | 2015-07-22 |
| Device Manufacturer Date | 2012-05-11 |
| Date Added to Maude | 2015-06-22 |
| 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 | 0 |
| Event Location | 0 |
| 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 | TREPHINE ATTACHMENT 5.5MM DIAMETER |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2015-06-22 |
| Returned To Mfg | 2015-07-22 |
| Catalog Number | 03.111.025 |
| Lot Number | 7854406 |
| 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 19380CH2 SZ 19380 CH25 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-22 |