MAUDE Adverse Event Report: ZIMMER GMBH SET SCREW, 8 MM, 21 MM, HEX 3.5 MM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy date detail of product: item number: 47249336011, item name z nail cpm 11.5mm x 36cm 125 r, lot# 2811445r; item number: 47248511010, item name z nail 10.5 x 110 lag screw, lot # 2811286.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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 Description

It was reported that the set screw was stuck during the procedure, also a second try with another set screw was not successful causing a delay over 30 minutes.

Event Description

Please refer to report 0009613350 - 2019 - 00146.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: h2 - h6.Correction: b4 - d10 - g4 - g7 - h10.Event: it was reported that the set screw was stuck during the procedure, also a second try with another set screw was not successful.It is unknown how the lag screw was fixed but one set srew will be returned.Harm: extended surgery time t > 30min.Hazard: does not fit or function.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.No relevant medical data has been received.Visual examination: only he set screw has been returned for investigation.The visual examination shows that the first and second thread of the screw is polished.This can be caused by trying to insert the set screw into the znn nail.It can be assumed that the set screw was not correctly placed into the znn nail.No other damas or deformations can be seen.Functional tes: a functional test was done with the affected set screw and znn nail (sample) ref 47-2493-182-13 lot 2626396.The set screw could be inserted into the znn nail.The function of the device is not affected.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: SET SCREW, 8 MM, 21 MM, HEX 3.5 MM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8446671
• MDR Text Key: 139671616
• Report Number: 0009613350-2019-00146
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298620
• UDI-Public: 00889024298620
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-000-00
• Device Lot Number: 15173132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other