MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE 1.7MM,CROSS-PIN,DENTAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	62-17333
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
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 customer reported that as the surgeon was implanting a screw into the finger of a male patient, the screw got stuck in the screwdriver.The surgeon tried to toggle the screwdriver to release the screw but this action pulled the screw out from the bone.The patient had osteoporosis.The case was completed successfully as there were other holes in the plate which could be used.There were no delays to surgery.The customer reported that this screwdriver has likely been on the set for nearly 10 years and is likely to be worn.The screwdriver has been quarantined from use.
Additional Manufacturer Narrative
Corrections to concomitant medical products and device evaluated by mfr.The reported event that screwdriver blade 1.7mm,cross-pin,dental was alleged of 'component/device stuck' could not be confirmed, since the device was not returned (got lost during transit to freiburg) for evaluation and no other evidences were provided.Note: the customer reported that this screwdriver has likely been on the set for nearly 10 years and is likely to be worn.The screwdriver has been quarantined from use.So based on that given information, the root cause was attributed to be other related.The failure was caused by normal wear and tear over the years.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.If any further information is provided, the investigation report will be updated.H3 other text : device was lost in transit.
Event or Problem Description
The customer reported that as the surgeon was implanting a screw into the finger of a male patient, the screw got stuck in the screwdriver.The surgeon tried to toggle the screwdriver to release the screw but this action pulled the screw out from the bone.The patient had osteoporosis.The case was completed successfully as there were other holes in the plate which could be used.There were no delays to surgery.The customer reported that this screwdriver has likely been on the set for nearly 10 years and is likely to be worn.The screwdriver has been quarantined from use.

• Brand Name: SCREWDRIVER BLADE 1.7MM,CROSS-PIN,DENTAL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8276292
• Report Number: 0008031020-2019-00047
• Device Sequence Number: 11240639
• Product Code: LXH
• UDI-Device Identifier: 04546540540935
• UDI-Public: 04546540540935
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 62-17333
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/05/2019
• 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