MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CAPTURED SCREWDRIVER SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 00249003562

Device Problem Fracture (1260)

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

Event Date 01/21/2024

Event Type  malfunction  

Event Description

It was reported that during an initial procedure, one (1) reamer and two (2) screwdriver tips were fractured, and a lag screw retaining shaft would not thread properly to the lag screw.The correct surgical technique was used.No complications, injuries, surgical interventions, or foreign bodies were retained due to this malfunction.The case was completed without any adverse outcomes to the patient.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see the associated reports: 0001822565-2024-00539; 0001822565-2024-00540.D10: concomitant medical products, part number (lot number): 00249003572 (65167222); 00249000364 (4504918744); 00249000353 (63272894).G2: foreign - the event occurred in south africa.E1: full establishment name - (b)(6).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CAPTURED SCREWDRIVER SHORT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18720118
• MDR Text Key: 335538667
• Report Number: 0001822565-2024-00538
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 00249003562
• Device Lot Number: 64580970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: H10
• Patient Sex: Prefer Not To Disclose