MAUDE Adverse Event Report: ZIMMER GMBH CMN SET SCREW TITANIUM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The manufacturer received product pictures for review.Device history record (dhr) review could not be performed as the lot number of the device involved in the event is unknown.The following report is associated with this event 0009613350 -2019 -00203.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that during a surgery, a set screw was stuck when being set and it couldn't be turned.The surgeon had to remove the znn nail and implant a back-up nail.There was a delay in the procedure of more than 30 minutes.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Device history records (dhr): the dhr check for ref.47-2493-000-00 could not be performed as the lot number was not available.Trend analysis: no trend has been identified.Event description: it was reported that during a surgery on (b)(6) 2019, a set screw was stuck when being set and couldn't be turned.The surgeon had to remove the znn nail and implant a back-up nail.There was a delay in the procedure of more than 30 minutes.No relevant medical data has been received.Visual examination: the set screw and the znn nail have been returned for investigation.The visual examination shows that the set screw was still inside znn nail.The set screw was removed from the nail.It can be seen the threads of the set screw were polished and damaged.This could possibly be caused by incorrect placement of the set into the nail.The products are intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: CMN SET SCREW TITANIUM
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8498489
• Report Number: 0009613350-2019-00204
• Device Sequence Number: 2675526
• Product Code: HSB
• UDI-Device Identifier: 00889024298620
• UDI-Public: 00889024298620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-000-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other