MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TREPHINE ATTACHMENT 10.5MM DIAMETER

Catalog Number	387.661
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of event is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Facility phone number is not provided for reporting.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the trephine-attachment broke during first use.No other information provided.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TREPHINE ATTACHMENT 10.5MM DIAMETER
• Common Device Name: TREPHINE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7366639
• Report Number: 8030965-2018-52365
• Device Sequence Number: 1216810
• Product Code: HWK
• UDI-Device Identifier: 07611819245068
• UDI-Public: (01)07611819245068(10)LOTNUMBERUNKNOWN
• 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
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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: 387.661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1