MAUDE Adverse Event Report: ZIMMER GMBH HUMERUS BALL NOSE GUIDEWIRE, STERILE; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D4.Product id was provided for two guidewires however, it is unknown which of the two has migrated.Therefore, the broken guidewire could be any of the following: 110035668 ¿ humerus ball nose guidewire ¿ 3185817.Udi: (b)(4), manufacturing date: dec 28, 2023, expiration date: dec 28, 2028.110035668 ¿ humerus ball nose guidewire ¿ 3197884 udi: (b)(4), manufacturing date: may 07, 2024, expiration date: may 07, 2029.G2.Report source: japan.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.
Event or Problem Description
It was reported that operation was performed with ann system.During the procedure, the nail was inserted by hitting it with a hammer with great force, which caused the inserted guide pin to bend and become stuck.Since the guide pin could not be manually pulled out, the guide pin was pulled out with a power tool.The nail and the guide pin rubbed against each other so hard that the tip of the guide pin broke off and remained inside the patient.No revision surgery is planned.Diligence is complete and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.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 histories found no additional related complaints for these items and the reported part and lot combinations.Of note, this complaint contains the same reported product twice, but with two different lot numbers, as two different guidewires were used in the same surgery, but no information was provided on which one fractured.Based on the information provided in the reported event and comparing this information to the surgical technique, it may be assumed that a potential user error may have caused or contributed to the reported event.However, with the available information, it is not possible to confirm and reproduce the reported event, and a definitive root cause cannot be established.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
Diligence is complete and no further information on the reported event has been provided.

• Brand Name: HUMERUS BALL NOSE GUIDEWIRE, STERILE
• Common Device Name: INSTRUMENT, 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: 20175024
• Report Number: 0009613350-2024-00439
• Device Sequence Number: 8138382
• Product Code: HSB
• UDI-Device Identifier: 00889024506558
• UDI-Public: (01)00889024506558(17)281228(10)3185817
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181827
• 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): 01/17/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110035668
• Device Lot Number: 3185817
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male