MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEX HEADED SCREW 3.5 MM HEX 48 MM LENGTH; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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.Concomitant medical products: 00590103548, hex headed screw 3.5 mm hex 48 mm length, 65307240.20090127agc, oscillating saw blade cutting: 90mm l x 20mm w x 1.27mm thick fits: zimmerâ®/synthesâ®, 372824.42509908562, - 4-in-1 anterior referencing cut guide size 7, unknown lot.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02255.
Event or Problem Description
It was reported that there were metal shavings related to the fixation of the cutting block and screws or saw blade.All metal shavings were retrieved from the patient's wound.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon further evaluation of this malfunction, this device malfunction has not caused a serious injury in this event or past events.Visual examination of the returned product shows signs of scratches.Photographs provided show metal shavings covered in blood.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.

• Brand Name: HEX HEADED SCREW 3.5 MM HEX 48 MM LENGTH
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15145867
• Report Number: 0001822565-2022-02256
• Device Sequence Number: 5197403
• Product Code: LXH
• UDI-Device Identifier: 00889024563193
• UDI-Public: (01)00889024563193(17)320307(10)65307240
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 00590103548
• Device Lot Number: 65307240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Patient Sex: Male