MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.8MM INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE; GUIDE

Catalog Number	03.124.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes sales consultant.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 synthes (b)(4) reports an event as follows: it was reported that on (b)(6) 2019, the thread of four variable angle locking compression plate (va-lcp) proximal tibia plates screw hole was broken by two (2) interlocking bolt.It was noted it had been connected very carefully.There was no procedure nor patient involvement.This report is for one (1) interlocking bolt.This is report 6 of 6 for (b)(4).

• Brand Name: 2.8MM INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8460411
• Report Number: 8030965-2019-62315
• Device Sequence Number: 16875452
• Product Code: FZX
• UDI-Device Identifier: 07611819458253
• UDI-Public: (01)07611819458253
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 01/11/2019

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: 03.124.006
• Device Lot Number: 9650144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1