MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/125 DEG TI CANN TFNA 440MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.234S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 reports an event in (b)(6) as follows: it was reported the set screw not engaging with the lag screw inside the nail during a nailing procedure on (b)(6) 2020.The nail was removed and a secondary nail implanted successfully.There was an unknown time of surgical delay due to the nail exchange intraoperatively.Concomitant devices: unknown lag screw (part/lot# unknown, qty1).Unknown locking screws (part/lot # unknown, qty unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 12MM/125 DEG TI CANN TFNA 440MM/RIGHT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10338979
• Report Number: 8030965-2020-05390
• Device Sequence Number: 2912336
• Product Code: HSB
• UDI-Device Identifier: 10886982097200
• UDI-Public: (01)10886982097200
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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 Model Number: 04.037.234S
• Device Catalogue Number: 04.037.234S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - SCREWS: LOCKING