MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER SHAFT, COMPRESSION T2 HUMERUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060263
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
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
It is reported that the screwdriver broke off at coupling piece during operation.
Additional Manufacturer Narrative
Evaluation revealed the compression screw driver had broken in the pre-determined breaking point.Additionally, the hexagon had broken, as well.The review of manufacturing documents revealed no deficiency in manufacturing.Hardness tests revealed no deficiency in material.Dimensional examination revealed no deviations in the relevant undamaged areas.A review of the fmea revealed that instrument breakage had been considered.Evaluation results did not indicate a non-conformity, adverse trend or unanticipated hazard.No further action is required at this time.Found evidences identified ¿ material orientation at the pre-determined breaking point ¿ that the screwdriver had been operated in right (clock-wise) direction when separated.Found evidences identified ¿ material orientation at the hexagon ¿ that the screwdriver had been operated in right (clock-wise) direction when separated.Both evidences identify the screwdriver broke due to increased overload during tightening procedure.The operative technique for the humeral nailing system instructs: ¿¿ the compression screw is gently tightened utilizing the two-finger technique¿¿ meaning the device is not intended for high load application.Further, the op-tech requires observation by imaging during compressing the bone fragments.By doing this it can be observed when the locking screws deforms ¿ indicating compression is at the maximum and requires no more load application.Referring to the period since distribution, roughly 15 years ago, it was concluded that the compression screwdriver had fulfilled its tasks as intended.As inspection of the returned product revealed no deficiency the reported event has to be classified as not device related.The event was caused by applied overload during the compression procedure which was regarded as a user related.The event was not caused by deficiency of the device.
Event or Problem Description
It is reported that the screwdriver brokee off at coupling piece during operation.

• Brand Name: SCREWDRIVER SHAFT, COMPRESSION T2 HUMERUS
• 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: 8276287
• Report Number: 0009610622-2019-00056
• Device Sequence Number: 10797601
• Product Code: LXH
• UDI-Device Identifier: 04546540196330
• UDI-Public: 04546540196330
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 18060263
• Device Lot Number: K0AB609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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