MAUDE Adverse Event Report: STRYKER GMBH LAG SCREWDRIVER GAMMA3® 380X110MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0200
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "spikes on screwdriver broken off at front, thread loose on wire." there was a 60 minute surgical delay.All debris was removed from the patient.
Event or Problem Description
As reported: "spikes on screwdriver broken off at front, thread loose on wire." there was a 60 minute surgical delay.All debris was removed from the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The device inspection revealed the following: the received lag screwdriver shows signs of intense usage evident by the presence of scratches and other usage marks.The pegs of the screwdriver are completely broken off.However, a sign of third-party refurbishment/rework was found as the font used for stryker and catalog marking is different from stryker¿s original marking as per the drawing, thus a further device inspection is deemed dispensable.A review of the device history was not possible because the lot number was not communicated.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.Based on the investigation it was found that although there was failure confirmation there was already a refurbishment which can be confirmed by font change from the stryker approved drawing and marking is not made by stryker at any point in time.Instruments that are refurbished by third parties/external sources and then returned to the customers are not regarded to have been put on the market by stryker.After any sort of rework is done externally, they become products of a third party.There are no warranty claims against stryker for third-party products.If any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Please refer to d3, h6 device code.
Event or Problem Description
As reported: "spikes on screwdriver broken off at front, thread loose on wire." there was a 60 minute surgical delay.All debris was removed from the patient.

• Brand Name: LAG SCREWDRIVER GAMMA3® 380X110MM
• 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: 16426613
• Report Number: 0009610622-2023-00057
• Device Sequence Number: 11418506
• Product Code: LXH
• UDI-Device Identifier: 04546540377807
• UDI-Public: 04546540377807
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1320-0200
• Device Catalogue Number: 13200200
• Device Lot Number: UNKNOWN
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/15/2023; 09/25/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 04/12/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 40 YR
• Patient Sex: Unknown