MAUDE Adverse Event Report: STRYKER GMBH ADJUSTMENT INSTRUMENT HOFFMANN LRF; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	4934-9-100
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during the startup of the surgery our sales rep discovered that one of the instrument trays was missing.Patient was asleep and the surgery could not take place and doctor had to reschedule this intervention to 13/04." kit room staff confirmed the missing instrument tray was not delivered and still in the kit room.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The complaint could be confirmed, since the information for evaluation matches the alleged failure.The inspection revealed the following: senior specialist raqa reviewed the received information and noted: an initial investigation points towards insufficient training.In regards to this specific case, the team had 1 tray incomplete, and that was kept in a different place to the 1st tray.This is because typically most kits in belgium are only set up as 1 bom/1 tray.To mitigate that in the short term, all multi tray kits will remain in the tote, even when partially incomplete, and this should avoid splitting the trays up during the inspection process.This should also be reflected on the tray, 1 of 2 etc and on the tote.We¿ve opened nc to investigate this occurrence.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.If more information is provided, the case will be reassessed.Device disposition unknown.
Event or Problem Description
As reported: "during the startup of the surgery our sales rep discovered that one of the instrument trays was missing.Patient was asleep and the surgery could not take place and doctor had to reschedule this intervention to 13/04." kit room staff confirmed the missing instrument tray was not delivered and still in the kit room.

• Brand Name: ADJUSTMENT INSTRUMENT HOFFMANN LRF
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16820735
• Report Number: 0008031020-2023-00165
• Device Sequence Number: 12523956
• Product Code: KTT
• UDI-Device Identifier: 07613327072921
• UDI-Public: 07613327072921
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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): 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4934-9-100
• Device Catalogue Number: 49349100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown