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	09/20/2018
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 the hex of the screwdriver rounded as the surgeon used it to turn the screw.The patient¿s bone was very hard and this may have made it more difficult.This did not affect the patient as we have similar screwdrivers on the set.
Event or Problem Description
The customer reported that the hex of the screwdriver rounded as the surgeon used it to turn the screw.The patient¿s bone was very hard and this may have made it more difficult.This did not affect the patient as we have similar screwdrivers on the set.
Additional Manufacturer Narrative
Referring to the product inquiry the screwdriver, self-holding is the only reported device and thus, considered the primary product.A review of the inspection records for the reported screwdriver revealed no discrepancies; the device was documented faultless prior to distribution.A performed function test with a sample screw revealed the screwdriver tip holds the screw without any problem.Function was proved fully given.The reported event ¿¿ the hex of the screwdriver rounded as the surgeon used it to turn the screw¿ could not be confirmed.The returned device does not show any deformation.The only explanation for the complaint is, that the customer was not familiar with the correct handling of the device.The self-holding screwdriver consists of two components: the slotted screwdriver itself (cat.# 18060233/1) and the sleeve with locking function (cat.# 18060233/2).When the two components are assembled and the sleeve is locked, the screwdriver tip is spreading.This is the self-holding function of the screwdriver.Based on the above facts the root cause of the reported event is not related to a deficiency of the device but is rather linked to improper handling by the user.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.

• 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: 7982075
• Report Number: 0009610622-2018-01347
• Device Sequence Number: 201612
• 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: company representative
• Initial Reporter Occupation: Other
• 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: KMW351301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/18/2018
• 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