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

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/12/2021

Event Type  Injury  

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 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 Description

No further event information available at the time of this report.

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
• Type of Device: 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
• MDR Text Key: 292225258
• Report Number: 0009613350-2022-00296
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298873
• UDI-Public: (01)00889024298873
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 51 KG