MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø10X400 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18251040S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device evaluated by mfr: implanted.
Event or Problem Description
Customer reported that surgeon performed a retrograde femoral nail on (b)(6) 2019 on a peri-prosthetic fracture.The attending theatre nurse informed (b)(4) that she had filed a report as the implant that was used had an expiry on 01/19.Surgeon was made aware of this before implanting but was happy to proceed.
Event or Problem Description
Customer reported that surgeon performed a retrograde femoral nail on tuesday (b)(6) 2019 on a peri-prosthetic fracture.The attending theatre nurse informed teknosurgical that she had filed a report as the implant that was used had an expiry on 01/19.Surgeon was made aware of this before implanting but was happy to proceed.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the event the most probable root cause would be user related issue as surgeon used an implant even after knowing that implant had expiry.The failure was caused due to not following the ifu which clearly mentions that for detailed information concerning the identification of the product (such as system association, catalog no.(ref), material, expiration date of sterile products) please refer to the marking on the product and/or the labeling of the package.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR Ø10X400 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
• MDR Report Key: 8601756
• Report Number: 0009610622-2019-00246
• Device Sequence Number: 19381445
• Product Code: HSB
• UDI-Device Identifier: 04546540199539
• UDI-Public: 04546540199539
• Combination Product (Y/N): N
• PMA/510(K) Number: K010801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 18251040S
• Device Lot Number: K0F3C27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR