MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPARE CENTERING PIN FOR HOLLOW REAMER (309.065)

Catalog Number	309.670
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no reported patient involvement.Date of event reported as (b)(6) 2018.It is unknown if that is the date the devices broke or the date they were discovered broken.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes sales consultant.(b)(4).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 devices were broken.There was no reported patient involvement.This is report 5 of 5 for (b)(4).

• Brand Name: SPARE CENTERING PIN FOR HOLLOW REAMER (309.065)
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7433375
• Report Number: 8030965-2018-53135
• Device Sequence Number: 11097802
• Product Code: HTO
• UDI-Device Identifier: 07611819018464
• UDI-Public: (01)07611819018464
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/27/2018

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: 309.670
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1