MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, LOCKING 3.1MM, SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	705004
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2020
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
As reported: when orif procedure for the distal tibia was performed, and after temporarily fixing the plate with k wire, drilling was done using a drill sleeve short.But the drill did not come off and removed together with the drill sleeve.
Event or Problem Description
As reported: when orif procedure for the distal tibia was performed, and after temporarily fixing the plate with k wire, drilling was done using a drill sleeve short.But the drill did not come off and removed together with the drill sleeve.
Additional Manufacturer Narrative
Correction: section d4 (lot #).The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following: the received drill and drill sleeve were received in a stuck state.Both were having signs of intense and frequent usage they both couldn¿t be dis-assembled.This gives a first indication that most likely a metal debris or bone residue is clogged inside the cannulation.Circular scratch marks were observed on the shaft of the drill just above the flutes.It resembles a pattern as if it was passed through the sleeve with a significant debris inside the cannulation.Drill flutes were also found significantly damaged, possibly due to a restricted movement of drill due to jamming.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Since the devices could not be dis-assembled, it was not possible to determine the exact root cause of the complaint.However, visual evidence indicates towards a potential clogging of the cannulation by metal debris generated inside due to a long and intense usage (manufactured in 2015).The device was manufactured in dec 2015.As the device had been in use for approx.4 years, we pre-suppose that it had fulfilled its tasks in former surgeries as intended without any reported failure before.If any further information is provided, the complaint report will be updated.

• Brand Name: DRILL SLEEVE, LOCKING 3.1MM, SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10158386
• Report Number: 0008031020-2020-01700
• Device Sequence Number: 2823740
• Product Code: LXH
• UDI-Device Identifier: 07613327083606
• UDI-Public: 07613327083606
• Combination Product (Y/N): N
• 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): 08/07/2020

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: 705004
• Device Catalogue Number: 705004
• Device Lot Number: K051BD6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1