MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125, LEFT, 10 MM, 21.5 CM; ROD, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign - (b)(6).Investigation of this incident is currently ongoing.A followup/ final report will be submitted when additional information becomes available.
Event or Problem Description
It was reported that: the patient underwent a revision procedure due to a bone fracture, 3 days post-op.Attempts have been made but no further information has been provided at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.As no product was returned, visual and dimensional evaluations could not be performed.The dhr review could not be performed due to missing product identification (lot number).Nevertheless, based on the given information there is no indication of a nonconformance or complaint out of box (coob).Surgical reports were received and reviewed.The surgeon had some difficulties in insertion of the nail.No other abnormalities were found.Revision report also mentions that this was a difficult surgery.X-rays were received however, these x-rays are not relevant for this complaint.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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: CMN FEMORAL NAIL, CCD 125, LEFT, 10 MM, 21.5 CM
• Common Device Name: ROD, FIXATION
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 14460453
• Report Number: 0009613350-2022-00296
• Device Sequence Number: 19953838
• Product Code: HSB
• UDI-Device Identifier: 00889024298873
• UDI-Public: (01)00889024298873
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 09/12/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-211-10
• Device Lot Number: UNKNOWN
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 51 KG