MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR 10X420 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1825-1042S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that : "when a t2 long femur nail was placed, when the nail holder was removed during closure, it was noticed that a "wire" came out of the nail, which was cut flush with the nail.The operators do not know exactly where the wire came from, the ancillary instruments and reamers are intact; they think it is the internal thread of the nail.There were no immediate consequences for the patient, but future removal of the nail may be more difficult if the thread is damaged".
Additional Manufacturer Narrative
The alleged event was confirmed.Review of device history, labelling, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No indications of material, manufacturing or design related problems were found during the document review.Without the implanted counterpart the appearance of the returned material did not allow a clear determination from where it came from.It could be a part of the internal winding of the nail¿s thread or even a part of the winding of an obliquely inserted locking screw.A clear root cause could not be determined.With available information a product deficiency was not verified.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.
Event or Problem Description
The customer reported that : "when a t2 long femur nail was placed, when the nail holder was removed during closure, it was noticed that a "wire" came out of the nail, which was cut flush with the nail.The operators do not know exactly where the wire came from, the ancillary instruments and reamers are intact; they think it is the internal thread of the nail.There were no immediate consequences for the patient, but future removal of the nail may be more difficult if the thread is damaged.".

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR 10X420 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11586432
• Report Number: 0009610622-2021-00435
• Device Sequence Number: 14191970
• Product Code: HSB
• UDI-Device Identifier: 04546540199546
• UDI-Public: 04546540199546
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K010801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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 Expiration Date: 11/30/2025
• Device Model Number: 1825-1042S
• Device Catalogue Number: 18251042S
• Device Lot Number: K075C42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1