MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE LAG SCREWDRIVER GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13200310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2019
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
It has been reported by the customer that the screwdriver was broken in the first use.
Additional Manufacturer Narrative
The reported event could be confirmed.Device inspection revealed the following: the u-blade lag screwdriver gamma3®, the inner rod and the compression wheel showed significant traces of an intense use.One of the pegs of the screwdriver received was found to be completely broken off.The broken off pieces were not returned.The breakage surfaces showed the typical structure of a forced, ductile fracture due to overload with an evident material displacement.A pre-damaging of the instrument in prior surgeries could not be excluded.A review of the device history for the reported 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.A review of the labeling did not indicate any abnormalities.Ifu clearly instructs user that, before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.Potentially reduced accuracy in guidance is usually found during functional check (required as per ifu).Pre-supposing that a check for damage / function was carried out prior to surgery, the cause of the event can only be found in the intra-operative procedure.Otherwise, the reported problem would have been realized at that time and another device would have been used.Based on investigation, the root cause was attributed to user related issue.The failure was caused by application of excessive force during prior procedure.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It has been reported by the customer that the screwdriver was broken in the first use.

• Brand Name: U-BLADE LAG SCREWDRIVER GAMMA3®
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8566531
• Report Number: 0009610622-2019-00231
• Device Sequence Number: 2191901
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: 04546540377845
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: 13200310
• Device Lot Number: K02DB02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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