MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SILICONE HANDLE QUICK COUPLING/SHORT; MISC ORTHO SURGICAL INSTR

Catalog Number	03.111.013
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
Additional narrative: device is not distributed in the united states, but is similar to device marketed in the usa.Investigation summary 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 history lot part: 03.111.013 lot: 2629301 manufacturing site: bettlach release to warehouse date: aug 19, 2010 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 reports an event in (b)(6) as follows: it was reported on an unknown date that the silicone handle was broken.Cause was unknown.There are no surgical procedure or patient involvement.This report is for 1 of 1 for (b)(4).

• Brand Name: SILICONE HANDLE QUICK COUPLING/SHORT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9261551
• Report Number: 8030965-2019-69871
• Device Sequence Number: 19470253
• Product Code: LXH
• UDI-Device Identifier: 07611819373334
• UDI-Public: (01)07611819373334
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/15/2019

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: 03.111.013
• Device Lot Number: 2629301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1