MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE SILICONE DRILL DRIVER; HIPS, INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the rubber is coming off the flexible silicone drill driver.There was no patient involvement reported.Attempts to obtain additional information have been made, however, no more is available.
Additional Manufacturer Narrative
(b)(4).31-323220 3.2mmx20mm rnglc+ acet drl bit 66040925; 010000660 g7 pps ltd acet shell 46b 7152794; 00-6250-065-25 bone screw 6.5x25 selftap 65885364; 30103202 g7 vit e neutral lnr 32mm b 65574688; 51-103100 tprlc 133 t1 pps so 10x140mm 7121925; 650-1056 cer bioloxd option hd 32mm 3133103; 650-1064 cer option type 1 tpr sleve -6 3130571.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
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.A flexible silicone drill driver, part # 110010733 from lot 196352, was returned and evaluated against the complaint.The lot on the driver matches the complaint.Visual inspection observed that the silicone sleeve has pulled away from the head of the driver exposing the wire shaft.One of the internal wires is deformed and ununiform.Scuffing is present on the connector.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.Event confirmed via returned product.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: FLEXIBLE SILICONE DRILL DRIVER
• Common Device Name: HIPS, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17271328
• Report Number: 0001825034-2023-01521
• Device Sequence Number: 3567344
• Product Code: HTW
• UDI-Device Identifier: 00887868466014
• UDI-Public: (01)00887868466014(11)210426(10)196352
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2023

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: 110010733
• Device Lot Number: 196352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Sex: Unknown