MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5050S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that an expired screw had been used during the gamma nail case on 19 april 2023.The implant is a 5x50mm locking screw ref 1896-5050s lot: k0bf71a with an expiry date of 31/03/2023.During the surgery the sales rep did not attend the case because of covid and the case went on its own.The implant was opened by the nurse on duty that day.
Event or Problem Description
It was reported that an expired screw had been used during the gamma nail case on (b)(6) 2023.The implant is a 5x50mm locking screw ref 1896-5050s lot: k0bf71a with an expiry date of 31/03/2023.During the surgery the sales rep did not attend the case because of covid and the case went on its own.The implant was opened by the nurse on duty that day.
Additional Manufacturer Narrative
The reported event could be confirmed, since as per the device label information, it expired on 31st march 2023 while the surgery happened after the expiry date.The device inspection was not possible as the product was not returned 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Information regarding the device, including its expiration date is clearly available on its packaging.Therefore, it is the responsibility of the operating surgeon and the staff to check that before the surgery.In case of the expiration of shelf-life stryker cannot guarantee the performance and safety for use.Re-sterilization is only possible for those devices where stryker explicitly describes a re-sterilization process it in the ifu.The risk of infection will increase with the time passed after the expiry date which is printed on the packaging.Also a local nc at distribution site was opened for this event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17183200
• Report Number: 0009610622-2023-00214
• Device Sequence Number: 6518475
• Product Code: HSB
• UDI-Device Identifier: 04546540202512
• UDI-Public: 04546540202512
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: 03/31/2023
• Device Model Number: 1896-5050S
• Device Catalogue Number: 18965050S
• Device Lot Number: K0BF71A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2018
• 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
• Patient Age: 56 YR
• Patient Sex: Female