MAUDE Adverse Event Report: STRYKER GMBH RECON TISSUE PROTECTION SLEEVE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23510190
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
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 sleeve for the recon lag screw did not be inserted smoothly into the hole of the target device.And when pulling it out, it is necessary to grab the sleeve with pliers and tap it out with a hammer.Since other sleeves can be inserted and pulled out, there seems to be no problem with the target device.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received sleeve shows significant traces of usage as evidenced by minor scratches and dents all over the body.The proximal area shows heavy scratches along with dents and the edges are also slightly worn-off.This is a clear indication of forcible use.A pre-surgical functional test was performed with the return device by using a sample target device.The sleeve was going smoothly in the target device until the proximal neck area from where it is heavily damaged.Hence the alleged issue was confirmed.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.Based on the investigation, the root cause was attributed to a user related issue.The failure was caused by inappropriate handling of the device at the time of usage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the sleeve for the recon lag screw did not be inserted smoothly into the hole of the target device.And when pulling it out, it is necessary to grab the sleeve with pliers and tap it out with a hammer.Since other sleeves can be inserted and pulled out, there seems to be no problem with the target device.".

• Brand Name: RECON TISSUE PROTECTION SLEEVE IMN INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 17465818
• Report Number: 0009610622-2023-00271
• Device Sequence Number: 2710328
• Product Code: LXH
• UDI-Device Identifier: 07613327368123
• UDI-Public: 07613327368123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/30/2023

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 Catalogue Number: 23510190
• Device Lot Number: KP431180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• 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
• Patient Sex: Female