MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.8MM THREADED DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	323.027
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part: 323.027-exs, lot: 2239836, manufacturing site: (b)(4), release to warehouse date: 13.March 2007.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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
Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that the drill guide was discovered to be broken.There was no patient involvement.This report is for one (1) 2.8mm threaded drill guide.This is report 1 of 1 for (b)(4).

• Brand Name: 2.8MM THREADED DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10396653
• Report Number: 8030965-2020-05899
• Device Sequence Number: 16795707
• Product Code: FZX
• UDI-Device Identifier: 07611819245907
• UDI-Public: 07611819245907
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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: 323.027
• Device Lot Number: 2239836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1