MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW REAMER, SHORT; TRAUMA INSTRUMENT

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Medical product: z nail 10.5 x 110 lag screw; catalog#: 47-2485-110-10; lot#: 3061196.Z nail 5.0x35 cort screw fa; catalog#: 47-2484-035-50; lot#: 65133376.Znn, cmn threaded pin, 3.2 mm; catalog#: 00-2490-450-32; lot#: unknown.Znn, cmn drill, calibrated, 4.3 mm; catalog#: 00-2490-066-43; lot#: unknown.Cmn femoral nail, ccd 130, left, 11.5 mm, 21.5 cm; catalog#: 47-2493-213-11; lot#: unknown.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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 during surgery the tip of the lag screw reamer fractured inside the patient.It was safely retrieved and confirmed with x-ray.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.

Manufacturer Narrative

Event: it was reported that: "lag screw reamer tip broke inside patient but was safely retrieved and confirmed with xray.- no relevant medical data has been received.- visual examination: the lag screw reamer was returned for investigation.It can be seen that the tip of the instrument was broken.The broken piece has not been returned for evaluation.No other damages or deformations can be detected.- the product is intended for treatment.- the investigation results did not identify a non-conformance or a complaint out of box (coob).- based on the lack of information regarding the event and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: ZNN, CMN LAG SCREW REAMER, SHORT
• Type of Device: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12589553
• MDR Text Key: 276577048
• Report Number: 0009613350-2021-00518
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024276260
• UDI-Public: 00889024276260
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-2490-003-64
• Device Lot Number: 16277660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female