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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a closure top starter fractured intra-op.A different driver was used to complete the case without patient impacts.
Additional 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 or Problem 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
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11268046
• Report Number: 3012447612-2021-00015
• Device Sequence Number: 14298712
• Product Code: HXX
• UDI-Device Identifier: 00887868266577
• UDI-Public: (01)00887868266577(10)AD64R
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1