MAUDE Adverse Event Report: ZIMMER BIOMET, INC. A/R SCREW DRILL; TRAUMA INSTRUMENTATION

Catalog Number 211201505

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).211201505 215530; manufacture date: nov 27, 2016; expiration date: nov 27, 2026; (b)(4).211201505 215540; manufacture date: nov 27, 2016; expiration date: nov 27, 2026; (b)(4).211201505 215560 manufacture date: nov 22, 2016; expiration date: nov 22, 2026; (b)(4).211201505 490720; manufacture date: sep 02, 2016; expiration date: sep 02, 2026; (b)(4).211201505 490710; manufacture date: sep 12, 2016; expiration date: sep 12, 2026; (b)(4).211201505 490700; manufacture date: sep 13, 2016; expiration date: sep 13, 2026; (b)(4).Concomitant medical product(s): unknown drill guide.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -04964; 0001825034 - 2019 -05037.

Event Description

It was reported that the patient underwent left orif.Subsequently, during drilling, the drill snapped and a portion was retained by the patient.A second drill was used freehand which fractured too.Later, it was identified that the guide was bent.No additional patient consequences were reported.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10 device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: A/R SCREW DRILL
• Type of Device: TRAUMA INSTRUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9291641
• MDR Text Key: 179610590
• Report Number: 0001825034-2019-04965
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211201505
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention