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

Model Number 1806-0370

Device Problems Separation Failure (2547); Misassembly by Users (3133)

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.

Event Description

It was reported the nail was attached to the handle backwards and would not come off.

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 visual inspection of the received nail holding screw shows flattened up threads at the crest section, and it is due to some external forces applied during use.Significant fretting marks running over the whole circumference were visible on the outer surface of the shaft of the nail holding screw close to the beginning of the thread.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Instruction for use states that ¿do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate! always treat the instrument carefully to avoid surface damage or alterations to the geometry.¿.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by handling failure during disassembling which led to damage of nail holding screws.If any further information is provided, the complaint report will be updated.

Event Description

It was reported the nail was attached to the handle backwards and would not come off.Additional information: the procedure could be completed successfully using freehand technique.

• Brand Name: NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12590476
• MDR Text Key: 275227678
• Report Number: 0009610622-2021-00741
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540196484
• UDI-Public: 04546540196484
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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
• Device Operator: Health Professional
• Device Model Number: 1806-0370
• Device Catalogue Number: 18060370
• Device Lot Number: K807975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2004
• 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