MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE SILICONE DRILL DRIVER; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat# 31-323230 lot# 66490986 3.2mmx30mm rnglc+ acet drl bit.G2: foreign: canada.The 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 during the surgery, the surgeon was trying to drill a screw hole, but with the resistance of the bone, the drill bit would not turn.The surgeon opened a backup tray to use another silicone drill driver.This time, with the same drill bit but a different drill driver it worked well.After the surgery, the silicone drill driver was examined, and it was noticed that the instrument is broken at the junction between the metal and the silicone.There was no known impact or consequences to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h6 visual examination of the returned product and pictures identified the sheath has indentations along with wear visible on the junction location.The drill bit was also returned.The bit was put into the drill and held with the drill spinning with the bit not moving.The complaint is confirmed based on the evaluation of the returned product.Dhr was reviewed and no discrepancies related 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 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.

• Brand Name: FLEXIBLE SILICONE DRILL DRIVER
• Common Device Name: INSTRUMENT, HIP
• 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: 19285458
• Report Number: 0001825034-2024-01205
• Device Sequence Number: 18249286
• Product Code: LPH
• UDI-Device Identifier: 00887868466014
• UDI-Public: (01)00887868466014(11)210426(10)196352
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 05/07/2024
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/24/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown