MAUDE Adverse Event Report: STRYKER GMBH DOUBLE DRILL GUIDE Ø3.5/2.5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705023
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2019
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 customer reported that the surgeon was operating on a distal medial tibia and that when using the 2.5 mm drill 705025s it snapped inside the drill sleeve and became stuck.There were no adverse events or surgical delays.The surgeon opened another set to complete the case.
Event or Problem Description
The customer reported that the surgeon was operating on a distal medial tibia and that when using the 2.5mm drill 705025s it snapped inside the drill sleeve and became stuck.There were no adverse events or surgical delays.The surgeon opened another set to complete the case.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by to much applied force (inadequate use).The device inspection revealed the following: the broken drill is completely stuck / seized up in the cannulation of the drill sleeve.Some bone debris was clearly evident after dismantling both parts (used the force of a hammer to get the drill bit out).It is clearly evident that big junks of bone debris caused the jamming of the drill bit, whereas the drill shaft broke as the surgeon clearly applied far too much mechanical force.Some damages of the drill guide are also evident when looking into the cannulation, due to the debris.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.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: DOUBLE DRILL GUIDE Ø3.5/2.5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8729064
• Report Number: 0008031020-2019-00723
• Device Sequence Number: 2004391
• Product Code: LXH
• UDI-Device Identifier: 07613327083101
• UDI-Public: 07613327083101
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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 Catalogue Number: 705023
• Device Lot Number: K048BC3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1