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

Model Number	1806-0233
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device cannot be decontaminated.
Event or Problem Description
The surgeon reported that a gamma nail was implanted in (b)(6) 2020 and the patient presented with a foreign body.The patient was revised on (b)(6) 2021 and the surgeon reported that the foreign body is the tip of a gamma 3 locking (expandable) screw driver.The surgeon reported that the unintended metal was found at the top of the patient's femur.Patient required reoperation surgery to remove the broken tip.
Event or Problem Description
The surgeon reported that a gamma nail was implanted on (b)(6) 2020 and the patient presented with a foreign body.The patient was revised on (b)(6) 2021 and the surgeon reported that the foreign body is the tip of a gamma 3 locking (expandable) screw driver.The surgeon reported that the unintended metal was found at the top of the patient's femur.Patient required reoperation surgery to remove the broken tip.
Additional Manufacturer Narrative
Correction; please refer to d9/h3, h6 method, results & conclusion codes.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the returned device shows intensive traces of use and is indeed broken.The moveable blade was found completely broken off at the level of the end of the slot.The breakage surface shows the typically structure of a brittle fracture, due to a bending overload.To prevent bending the screwdriver (sleeve) is laser-marked with the printing ¿do not lever¿.Also, this is not the correct instrument to use.The device history record could not be reviewed because the affected device was not completely returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The operative technique instructs user that: ¿assemble the set screw to the set screwdriver.¿ formal medical opinion was sought from an experienced independent medical expert as below; ¿the insertion of the set screw should be performed with the flexible set screwdriver.The probable root cause of the screwdriver tip breakage is improper use of the wrong instrument.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused by improper use of the wrong instrument.The insertion of the set screw should be performed with the flexible set screwdriver.The optech also states ¿assemble the set screw to the set screwdriver.¿ also, the breakage indicates it to be a brittle fracture due to a bending overload.If the remaining part of the device is returned or any further information is provided, the investigation report will be reassessed.

• 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; GM D-24232
• MDR Report Key: 11481647
• Report Number: 0009610622-2021-00418
• Device Sequence Number: 19686179
• Product Code: LXH
• UDI-Device Identifier: 04546540520425
• UDI-Public: 04546540520425
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: Lay User/Patient
• Device Model Number: 1806-0233
• Device Catalogue Number: 18060233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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