MAUDE Adverse Event Report: ZIMMER GMBH ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 95 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that it was noted during a revision that after the locking screw removal, we were unable to remove the head screw from the nail and consequently the nail itself.The screwdriver could not, in any case and after several attempts, be fixed on the cephalic screw in place.The surgeon had a good vision of the screw and it had been cleared of any bony elements that could interfere between the screw and the screwdriver.Attempts have been made and additional information on the reported event has not yet been provided.
Additional Manufacturer Narrative
(b)(4).D10: unknow item #, unknow znn long trochanteric nail, lot #: unknown.G2: report source france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d10; g3; h2; h3; h6.D10: item # 00-2490-003-51 lot #62859637 long cm lag scrw retain shaft.Item # 00-2490-003-50 lot #64495544 long cm lag screw inserter.Item # 47-2493-381-11 lot #3134388 z nail cpm 11.5mm x 38cm 125 l.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.A definitive root cause could not 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.
Event or Problem Description
No additional event information at this time.

• Brand Name: ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 95 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19701990
• Report Number: 0009613350-2024-00285
• Device Sequence Number: 3702677
• Product Code: HSB
• UDI-Device Identifier: 00889024298446
• UDI-Public: (01)00889024298446(17)271220(10)3140285
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/12/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47248509510
• Device Lot Number: 3140285
• Was Device Available for Evaluation?: No
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 64 KG