MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER BIT IMPLANT EXTRACTION SET T20; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-6120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the surgeon had to remove an old strumentation from the vertebral column of the patient.While trying to unscrew a nut the screwdriver broke".
Event or Problem Description
As reported: "the surgeon had to remove an old strumentation from the vertebral column of the patient.While trying to unscrew a nut the screwdriver broke".
Additional Manufacturer Narrative
Correction: please refer to d9/h3 device not returned for evaluation.The reported event was not confirmed.Although announced the device was not returned for unknown reasons.No deviations were found during review of the manufacturing and inspection documents (dhr).The risk management file review showed that the complained event was addressed adequately; no threshold exceedances found.No nc/capa record was filed regarding the item in question with this failure mode.In the case presented an old instrumentation should be removed from the vertebral column of the patient.A product for a vertebral column is not in the portfolio of the manufacturer.The manufacturer only recommends use of the extractor instruments with its own products.With available information no product deficiency was determined.The event was regarded as off-label-use / user related.In case further information becomes available we reserve the right to reopen the investigation and to re-assess the root cause.H3 other text : device disposition is unknown.

• Brand Name: SCREWDRIVER BIT IMPLANT EXTRACTION SET T20
• 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: 11532244
• Report Number: 0009610622-2021-00424
• Device Sequence Number: 5169895
• Product Code: LXH
• UDI-Device Identifier: 07613154403868
• UDI-Public: 07613154403868
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/24/2021

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 Model Number: 1806-6120
• Device Catalogue Number: 18066120
• Device Lot Number: KSS19905N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR