MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TREPHINE ATTACHMENT 12.5MM DIAMETER

Catalog Number	387.662
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during an unknown surgery performed on (b)(6) 2018, the trephine broke off and one of the tips created shards when doing do.X ray was used to determine nothing was left in the patient and surgeon was satisfied.The bone harvesting had been achieved so it was only the process of removing the shards that caused the delay.This report is for one (1) trephine attachment 12.5mm diameter (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Patient ethnicity is unknown.Part: 387.662; lot: 9035629; manufacturing site: bettlach; release to warehouse date: september 04, 2014; the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.The review has shown that the correct material was used, and that the hardness was within 53-56 hrc as required.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The complaint is confirmed as the broken device is visible on the received picture.The manufacturing documents were reviewed, and no complaint related issues were found.Product was not returned, therefore no further investigation is possible.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
Event or Problem Description
The fragments were easily retrieved.Procedure was completed with a five minute delay.Patient status was okay.

• Brand Name: TREPHINE ATTACHMENT 12.5MM DIAMETER
• Common Device Name: TREPHINE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7634023
• Report Number: 8030965-2018-54571
• Device Sequence Number: 13900263
• Product Code: HWK
• UDI-Device Identifier: 07611819245259
• UDI-Public: (01)07611819245259
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 387.662
• Device Lot Number: 9035629
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR