MAUDE Adverse Event Report: STRYKER GMBH BODY ASSEMBLY DJD DISTRACTOR II; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM

Catalog Number	51950010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
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: "the hinge part of the djd2 body was disassembled and no longer fixed.It continued to be used with the defective part taped in place.".
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that the instrument is in a very bad condition with scratches, dent and deformations.By the adjustment mechanism and in the sleeve are some red foreign substance visible.Furthermore, the hinge is in a really bad condition with black foreign substance (sticky) and deformation, from use.In addition, microscopic investigation has shown that there are clear indications that the radially riveted (flanged) got damaged after manufacturing and based on that was able to fall off, visible as based on the cone from radially riveted process, and burr which is a result of continuously mechanical force to the radially riveted from use.Functional examination of the received product shows that the instrument was received with completely blocked adjustments mechanism in far short condition, with force we were able to unblock the instrument.Furthermore, we are able to confirm that the hinge can be disassembled, as the sleeve can be removed and based on that the hinge will fall apart.All measure results are within accuracy.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.100% of the lot got check for hinge function.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a use related issue.The failure was caused most likely the collapse of the radially riveted as result of continuously mechanical force.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the hinge part of the djd2 body was disassembled and no longer fixed.It continued to be used with the defective part taped in place.".

• Brand Name: BODY ASSEMBLY DJD DISTRACTOR II
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM
• 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: 19690370
• Report Number: 0008031020-2024-00260
• Device Sequence Number: 20613483
• Product Code: LXT
• UDI-Device Identifier: 07613327073713
• UDI-Public: 07613327073713
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 51950010
• Device Lot Number: H32709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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: Required Intervention
• Patient Sex: Unknown