MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. STARTER AWL; PROBE

Catalog Number LV01333

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that the awl broke during surgery.The tip was retrieved and an alternate was used to complete the case.There were no reported patient impacts.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The dhr was reviewed.There were no nonconformances or temporary deviations associated with this failure on this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.The device was not returned for further investigation nor were pictures submitted by the user.Therefore, a definitive root cause was unable to be determined.Review of complaint history for pn lv01333, ln 311460, identified 0 additional complaints for the same or similar issue in the 12 months leading up through the complaint date to the present.Additionally, 0 total other complaints were found for the same ln 311460.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that the awl broke during surgery.The tip was retrieved and an alternate was used to complete the case.There were no reported patient impacts.

• Brand Name: STARTER AWL
• Type of Device: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10687580
• MDR Text Key: 211669710
• Report Number: 3012447612-2020-00616
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00880304832374
• UDI-Public: (01)00880304832374(10)311460
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LV01333
• Device Lot Number: 311460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1