MAUDE Adverse Event Report: STRYKER GMBH NAIL HOLDING SCREW GAMMA3 8X35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200090
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Nail holding screw did not loosen with normal force.Eventually, the device was removed, but damage of the nail holding screw and strike plate was observed.There patient had no impact and surgery completed successfully.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was received worn out as reported.The device inspection revealed the following: the device is heavily worn out.Numerous marks of wear can be seen on the shaft.The head of the screw is broken, some of the fragments were returned.The breakage may give indication of careless and not recommended handling of the instrument, such as repetitive hammering and excessive torque when tightening the screw.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.Based on investigation, the root cause was attributed to an user related issue.The failure was probably caused by a combination of normal wear and not recommended handling of the device such as excessive torque applied when tightening the screw and repetitive hammering.It has to be taken into account that the device was manufactured in 2004, meaning it was used for approximately 20 years.As a reminder, the instructions for use states: before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.During the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
Nail holding screw did not loosen with normal force.Eventually, the device was removed, but damage of the nail holding screw and strike plate was observed.There patient had no impact and surgery completed successfully.

• Brand Name: NAIL HOLDING SCREW GAMMA3 8X35MM
• 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: 19705106
• Report Number: 0009610622-2024-00428
• Device Sequence Number: 20779816
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 13200090
• Device Lot Number: K574737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2004
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female