MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER, SELF-HOLDING, LONG SCREWDRIVER, SELF-HOLDING 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060233
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2018
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
The niaic report said that the tip of the screw driver noted to be broken when the scrub nurse tried to attach the last screw.It was found in the patient under x-ray.
Additional Manufacturer Narrative
The reported event that screwdriver, self-holding, long screwdriver, self-holding 3.5 mm was alleged of issue a (instruments - broken or deformed screwdriver) could be confirmed since the device was returned for evaluation and it matches the reported failure mode.A review of the device history for the returned lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.The returned device screwdriver, self-holding, long screwdriver, self-holding 3.5 mm shows traces of extensive usage.The reported screwdriver is indeed broken.It is lacking a small piece of material at the tip.This small piece is the one that allows the locking mechanism of this screwdriver to work and hold on to the screw when locked.A functional inspection does not make sense because the screw will fall every time.All materials which are used for implants (titanium) and for surgical instruments (stainless steel) are tested for biocompatibility.Based on the investigation results the case is attributed to an inadequate usage (user related).A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The niaic report said that the tip of the screw driver noted to be broken when the scrub nurse tried to attach the last screw.It was found in the patient under x-ray.

• Brand Name: SCREWDRIVER, SELF-HOLDING, LONG SCREWDRIVER, SELF-HOLDING 3.5 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7820644
• Report Number: 0009610622-2018-01034
• Device Sequence Number: 11062271
• Product Code: LXH
• UDI-Device Identifier: 04546540520425
• UDI-Public: 04546540520425
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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 Catalogue Number: 18060233
• Device Lot Number: KMW350802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other