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

Model Number	1806-0238
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Case has occurred during a g3 surgery.When locking the distal 5mm screw, half of the hex was broken off the self-holding screwdriver.This event was not detected during surgery.Only one day later in the control x-ray it was seen that part of the screwdriver was inside the patient.The patient was re-operated on (b)(6) 2020 and the broken part was removed.
Event or Problem Description
Case has occurred during a g3 surgery.When locking the distal 5mm screw, half of the hex was broken off the self-holding screwdriver.This event was not detected during surgery.Only one day later in the control x-ray it was seen that part of the screwdriver was inside the patient.The patient was re-operated on (b)(6) 2020 and the broken part was removed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the reported failure.The device inspection revealed the following: the returned screwdriver with the self-holding feature shows normal traces of use.However, the outer sleeve was not returned for evaluation, therefore a device identification was not possible.The breakage surface shows the typical characteristics of a forced brittle fracture.On one of the edges, deformation marks can be observed which under normal usage doesn¿t appear.All these signs are indicative of the fact that the screwdriver was overloaded and improperly handled.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A process change was performed with ecn# 6452/08; the wch coating was removed to prevent breakages of the moveable blade.The returned screwdriver manufacturing date post-dates the process change.Furthermore it is recommended that the screwdriver shall be treated with an appropriate instrument spray after every usage (was implemented with ecn# 6455/08).Thus no further changes is required.A review of the labeling did not indicate any abnormalities.The appearance of the breakage surface indicates a (forced) brittle breakage of the blade of the screw driver due to bending and rotational forces overload.It was also communicated through the additional communication that ¿a lot of force was used when turning in the screw¿.Based on the above facts the root cause of the reported event is breakage under overloading of screwdriver due to inadequate handling by the user.Also, since the outer sleeve was not returned there is a strong likelihood of the fact that the screwdriver was used without it during the surgery.Under such a usage, the blade is susceptible to break.However, this fact could not be confirmed.If any further information is provided, the complaint report will be updated.

• Brand Name: SCREWDRIVER, SELF-HOLDING, SHORT 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; GM D-24232
• MDR Report Key: 10748699
• Report Number: 0009610622-2020-00613
• Device Sequence Number: 3188585
• Product Code: LXH
• UDI-Device Identifier: 04546540520432
• UDI-Public: 04546540520432
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1806-0238
• Device Catalogue Number: 18060238
• Device Lot Number: KMW351201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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: Required Intervention
• Patient Age: 83 YR