MAUDE Adverse Event Report: STRYKER GMBH NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 1806-0370

Device Problems Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487)

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

Event Date 04/27/2022

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 nail holding screw can no longer be pushed through the nail holding bracket.".

Event Description

As reported: "the nail holding screw can no longer be pushed through the nail holding bracket.".

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 outer surface of the nail-holding screw shows signs of damage.A closer observation of the circumference of the outside of the screw at the beginning of the threads shows fretting marks which are due to improper use of the device.Further, the head near the thread side shows deformed surfaces that may be due to repetitive hitting or long use.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 and provided information, the root cause was attributed to a user-related issue.The failure was caused by the handling failure during assembling and dissembling which led the holder to damage and eventually impaired assembly with the holding screw.If any further information is provided, the complaint report will be updated.

Manufacturer Narrative

Please refer to d3 and h6 device code.

Event Description

As reported: "the nail holding screw can no longer be pushed through the nail holding bracket.".

• Brand Name: NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM
• 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: 14487580
• MDR Text Key: 292504268
• Report Number: 0009610622-2022-00209
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540196484
• UDI-Public: 04546540196484
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1806-0370
• Device Catalogue Number: 18060370
• Device Lot Number: KSS177H88
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• 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