MAUDE Adverse Event Report: STRYKER GMBH DRILL GUIDE Ø2.5MM, NON-LOCKING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705022
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2019
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
Primary procedure, left proximal humerus.It was reported that a drill bit bound up in the 2.5 drill guide and got stuck.When trying to remove the bit, approximately 60mm broke off in the guide.Procedure was completed free-handed, with a surgical delay of approximately 2 minutes reported.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
Event or Problem Description
Primary procedure, left proximal humerus.It was reported that a drill bit bound up in the 2.5 drill guide and got stuck.When trying to remove the bit, approximately 60mm broke off in the guide.Procedure was completed free-handed, with a surgical delay of approximately 2 minutes reported.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
Additional Manufacturer Narrative
The reported event that drill guide ø2.5mm, non-locking was alleged of 'component/device stuck' could not be confirmed, since the returned device is conforming to specifications and fully functional and the mentioned drill bit 700347 was not returned for investigation.No failure was detected.More detailed information about the complaint event as well as the affected device (drill bit) must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: 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.A sample drill bit was pushed into the cannulation of the drill guide without any problems at all.So the drill guide is fully functional.Unfortunately the mentioned drill bit 700347 was not returned for investigation.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: DRILL GUIDE Ø2.5MM, NON-LOCKING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8287415
• Report Number: 0008031020-2019-00054
• Device Sequence Number: 1947261
• Product Code: LXH
• UDI-Device Identifier: 07613327083491
• UDI-Public: 07613327083491
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 03/29/2019

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: No Information
• Device Catalogue Number: 705022
• Device Lot Number: K0B9407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/29/2019
• 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: Other
• Patient Age: 49 YR