MAUDE Adverse Event Report: SYNTHES GMBH MULTIFUNCTION ROD FOR INSERTION INSTS; APPLIANCE,FIXATION,NAIL

Catalog Number	03.168.010
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) 2021, the patient underwent for a surgery.During the surgery, the multifunction rod item turned out to be defective.The thread on the tip did not go into the screw due to damage.It was unknown how the damage occurred.It was unknown if the surgery completed successfully.The patient outcome was unknown.Concomitant device reported: unknown screw (part# unknown; lot# unknown; quantity: 1).This complaint involves one (1) device.This report is for (1) multifunction rod for insertion insts.This report is 1 of 1 (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part 03.168.010, lot 3l90427: release to warehouse date: april 29, 2019.Manufacturer: balsthal.No non-conformance reports (ncr's) were generated during production.H3, h6: a product investigation was completed: visual inspection of the complaint device showed the distal threaded bold tip was warped.No other defect was observed.A functional assessment was not performed with the complaint device due to the post manufacturing damage of the device.Dimensional inspection showed the relevant dimensions were conforming.The current and manufactured to drawings were reviewed; no design issues or discrepancies were identified.This complaint is confirmed as the thread tip was found wrapped.The stripped condition of the device caused it to not assemble with mating device.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

• Brand Name: MULTIFUNCTION ROD FOR INSERTION INSTS
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11660842
• Report Number: 8030965-2021-02866
• Device Sequence Number: 3084548
• Product Code: KTT
• UDI-Device Identifier: 07611819657366
• UDI-Public: (01)07611819657366
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 03.168.010
• Device Lot Number: 3L90427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA