MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS 5X55MM; SCREW, FIXATION, BONE

Model Number	2360-5060S
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: screw in incorrect packaging.Advanced locking screw - in locking screw packaging.Updated information: the surgeon was screwing the screw into a t2 recon femoral nail.The surgeon couldn¿t get it to screw in.They then saw on x-ray that it might be an advanced locking screw.The screw was then removed which proved it was an advanced locking screw.The screw was sealed in the pictured packaging before opening and inserting.Another screw was opened and used.
Additional Manufacturer Narrative
Correction: please refer to d4 catalog, lot and gtin number.The reported event could not be confirmed, since the dhrs revealed that both lot codes were manufactured and distributed at different times.A detailed review of the dhrs revealed the following: lot code k07de37 (b)(6) were manufactured, packed, finally released in september 2018 and distributed in full quantity between november 2018 and march 2019.Lot code k0e4708 (b)(6) were manufactured, packed, finally released in july 2019 and distributed in full quantity between march 2020 and april 2020.No discrepancies could be verified within the dhrs and statistics for the given lots.The alleged affected packaging was labelled almost one year after the reported advanced locking screw was manufactured and distributed in full quantity.Thus, we exclude a manufacturing error resp.A mix-up at the manufacturing site.Review of stock movement revealed that both lot codes were distributed to syk dist australia.Known from a previous similar case and based on above facts it could not be excluded that it¿s rather related to a deficiency in the further treatment at hospital.Referring to event description ¿¿they then saw on x-ray that it might be an advanced locking screw¿¿ but this could have been noticed at the time of implant identification.The ifu points out that inspection is recommended before surgical procedure to ensure that all components needed for the operation are available in the operation theatre.Finally, it is common practice to have a spare part available within the op-room during the surgical procedure.A review of the device history for the reported lot[s] 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 material, manufacturing or design related problems were found during the investigation.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: screw in incorrect packaging.Advanced locking screw - in locking screw packaging.Updated information: the surgeon was screwing the screw into a t2 recon femoral nail.The surgeon couldn¿t get it to screw in.They then saw on x-ray that it might be an advanced locking screw.The screw was then removed which proved it was an advanced locking screw.The screw was sealed in the pictured packaging before opening and inserting.Another screw was opened and used.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS 5X55MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11952646
• Report Number: 0009610622-2021-00541
• Device Sequence Number: 11819687
• Product Code: HWC
• UDI-Device Identifier: 07613327368574
• UDI-Public: 07613327368574
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 08/31/2023
• Device Model Number: 2360-5060S
• Device Catalogue Number: 23615055S
• Device Lot Number: K07DE37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1