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

Catalog Number	23510190
Medical Device Problem Codes	Failure to Align (2522); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
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 jig missed the recon screw.Trochars got stuck in the jig.Case was extended by roughly an hour.We had to manipulate the trocars many times to get it right but didn't use other instruments".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was found to be fully functional.A device inspection revealed the following: the returned tissue protection sleeves show obvious signs of usage evident by worn off surfaces and scratches.The only significant observation was that the tip of the sleeves was slightly worn out, one more than the other.However, it didn't affect the insertion of the k-wire sleeves in any way.A pre-surgical functional test was performed with the returned devices and some sample devices (k-wire & recon sleeve).It was observed that the k-wire sleeves and the tissue protection could be easily assembled together and with the target device as well without any jamming.The targeting accuracy was also given.The sleeve clamping feature is as intended.Thus, the alleged issue could not be reproduced and could not be 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 above investigation, the issue is deemed to be user related since the alleged issue could not be reproduced.The function of target device along with all the sleeves was given as intended.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: " the jig missed the recon screw.Trochars got stuck in the jig.Case was extended by roughly an hour.We had to manipulate the trocars many times to get it right but didn't use other instruments.".

• 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: 18044448
• Report Number: 0009610622-2023-00384
• Device Sequence Number: 15328341
• Product Code: LXH
• UDI-Device Identifier: 07613327368123
• UDI-Public: 07613327368123
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: KP423345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2018
• 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: Unknown