MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXACT REV FP RASP 13; HIP INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.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: 0001825034-2020-01242, 0001825034-2020-01244, 0001825034-2020-01245, 0001825034-2020-01246, 0001825034-2020-01247.
Event or Problem Description
It was reported that a rasp instrument for size 13 was etched for size 14 and visa versa.There is no known harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g4; h2; h3; h6.Visual review of provided photographs showed the size 13 rasps to be slightly larger than the size 14 rasp.No damages were observed and no further evaluation was possible with the images provided.Dhr was reviewed and no discrepancies were found.The investigation has concluded that the root cause can be attributed to a manufacturing deficiency.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 additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: remove code 4114: device was returned.Complaint sample was returned and evaluated against the reported event.Visual inspection identified wear and tear on all products consistent with previous usages.Measurement of overall lengths using calipers identified the rasps marked size 13 measured 6.5490 and 6.5515 confirming that are size 14.The rasps marked size 14 measured 6.3430 and 6.3415 confirming they are size 13.No other damaged are noted.Evaluation of the returned product does not change the final conclusions of the previous investigation.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.

• Brand Name: EXACT REV FP RASP 13
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9865957
• Report Number: 0001825034-2020-01243
• Device Sequence Number: 10893840
• Product Code: HTQ
• UDI-Device Identifier: 00889024584907
• UDI-Public: (01)00889024584907
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2021

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: SSI005613
• Device Lot Number: 97018262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 07/29/2020; 03/16/2021
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 07/30/2020; 03/17/2021
• 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