MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL PIN AND SCREW INSERTER; INSTRUMENT

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565-2021-00413.
Event or Problem Description
It was reported that uka was performed with ppk and when the drill pin was inserted into a pin hole of tibia cut guide drill pin broke and it was stuck in the pin driver.Subsequently, (b)(6) instead of the driver was used to complete the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product showed signs of repeated use.The drill pin was fractured and the pin driver showed wear in the hex feature, however, no component was identified o be jammed in the pin driver.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: DRILL PIN AND SCREW INSERTER
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11337227
• Report Number: 0001822565-2021-00414
• Device Sequence Number: 11430876
• Product Code: LXH
• UDI-Device Identifier: 00889024201637
• UDI-Public: (01)00889024201637(10)64152317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 00590102100
• Device Lot Number: 64152317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ITEM 00590102000, LOT 64558424.; ITEM 00590102000, LOT 64558424.