MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS MIS TARGETING GUIDE LG LT; INSTRUMENT, TRAUMA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that operation was performed with alps.During the procedure, when the surgeon tried to remove the guide from the plate, convex tip of the guide was broken and tip parts were remained inside the plate hole.No additional information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by visual evaluation of the device.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual examination of the returned product identified two posts have fractured off and not all the pieces were returned.Item and lot numbers verified.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: ALPS MIS TARGETING GUIDE LG LT
• Common Device Name: INSTRUMENT, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11174119
• Report Number: 0001825034-2021-00089
• Device Sequence Number: 3582976
• Product Code: HRS
• UDI-Device Identifier: 00887868457784
• UDI-Public: 00887868457784
• Combination Product (Y/N): N
• PMA/510(K) Number: K132898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110008305
• Device Lot Number: 475598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 01/15/2021
• 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
• Outcome Attributed to Adverse Event: Other