MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FORCEPS, SMALL IMPLANT EXTRACTION SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 1806-6178

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem Limb Fracture (4518)

Event Date 09/22/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "difficulty extracting an implant whilst using a stryker extraction set.Patient had a femoral fracture.".

Event Description

As reported: "difficulty extracting an implant whilst using a stryker extraction set.Patient had a femoral fracture.".

Manufacturer Narrative

Please note the correction to h6 device code.The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the outer surface of the received device shows signs of frequent usage.Overall no damage or deformation was observed on the device.A pre-surgical function test was performed on the returned device and was found to be fully functional.Hence the alleged issue could be reproduced.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 and information provided the exact root cause could not be established.However, most likely the failure seems to be a user-related issue.If any further information is provided, the complaint report will be updated.

• Brand Name: FORCEPS, SMALL IMPLANT EXTRACTION SET
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 15624696
• MDR Text Key: 301913854
• Report Number: 0009610622-2022-00467
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540510136
• UDI-Public: 04546540510136
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/09/2023

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
• Device Operator: Health Professional
• Device Model Number: 1806-6178
• Device Catalogue Number: 18066178
• Device Lot Number: KP470697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• 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
• Patient Outcome(s): Other