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

Catalog Number 23510190

Device Problems Failure to Align (2522); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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.".

Event 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.".

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.

• Brand Name: RECON TISSUE PROTECTION SLEEVE IMN INSTRUMENTS
• Type of Device: 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: 18511245
• MDR Text Key: 333212394
• Report Number: 0009610622-2024-00031
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23510190
• Device Lot Number: KP423345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1