MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SHEAR-OFF CLOSURE TOP STARTER; SCREWDRIVER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that a closure top starter fractured intra-op.A different driver was used to complete the case without patient impacts.

Manufacturer Narrative

Corrected information in h3.Additional information in h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information.The complaint is confirmed for one returned starter for the failure of fractured tip.Visual inspection revealed the tip insert has fractured from the device, making the device no longer functional.The tip insert was not returned for evaluation.Potential cause the cause of the damage cannot be determined at this time since there is no information available regarding how the closure top starter was being used or handled at the time of the damage.It's possible off-axis forces capable of over-coming material properties.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.

Event Description

It was reported that a closure top starter fractured intra-op.A different driver was used to complete the case without patient impacts.

• Brand Name: SHEAR-OFF CLOSURE TOP STARTER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11268046
• MDR Text Key: 230116550
• Report Number: 3012447612-2021-00015
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00887868266577
• UDI-Public: (01)00887868266577(10)AD64R
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

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 Model Number: N/A
• Device Catalogue Number: 730M0050
• Device Lot Number: AD64R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1