MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH SETTING INSTRUMENT FOR POLE PLUG; HIP INSTRUMENT

Model Number N/A

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

It was reported that there was a crack on the handle of the instrument.During investigation the tip of the instrument was seen to be fractured off and the ring was missing.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Report source - canada.The setting instrument has been returned for an investigation.A surface alteration is detected as the entire metal part of the instrument seems matt.The blue handle of the instrument shows a small crack.The tip of the instrument has fractured off and the ring is missing.Additionally, there is no lot number but the laser-marking 11-14 visible on the instrument.Review of the device history records could not be done as the lot number was not seen on the device.Device is used for treatment.Insufficient information provided.Unable to perform a compatibility check.The root cause of the reported event was determined to be related to a previously identified design issue.The device has since undergone a design enhancement through the capa process to address this issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SETTING INSTRUMENT FOR POLE PLUG
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 15415816
• MDR Text Key: 302777058
• Report Number: 0009613350-2022-00470
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• 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: 01.00009.001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose