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

Model Number	1806-0263
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
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
The product specialist reported that the it broke during use.It broke during final tightening of the compression screw but he was able to finish.It prolonged the operation with 15-20 min but he is happy with the results.No impact on patient.It broke up at the attachment to the handle.He bent it more and could use a chuck to hold it to be able to tighten the last bit.
Event or Problem Description
The product specialist reported that the it broke during use.It broke during final tightening of the compression screw but he was able to finish.It prolonged the operation with 15-20 min but he is happy with the results.No impact on patient.It broke up at the attachment to the handle.He bent it more and could use a chuck to hold it to be able to tighten the last bit.
Additional Manufacturer Narrative
Correction: refer to h6 health impact code.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 received screwdriver shaft was found to be bent and broken around the proximal region.It broke up at the attachment to the handle.The device was manufactured in 2015, so it can be said that it has performed its function in the previous surgeries as intended without any reported failure.Since it has been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use states: ¿always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.The stryker "instructions for cleaning, sterilization, inspection and maintenance" help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.¿ based on investigation, the root cause was attributed to a normal wear related issue.If any further information is provided, the complaint report will be updated.

• 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; GM D-24232
• MDR Report Key: 10576678
• Report Number: 0009610622-2020-00541
• Device Sequence Number: 3507378
• Product Code: LXH
• UDI-Device Identifier: 04546540196330
• UDI-Public: 04546540196330
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 01/04/2021

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: 1806-0263
• Device Catalogue Number: 18060263
• Device Lot Number: K076297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1