MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT Ø2.5X125MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	700347
Health Effect - Clinical Code	No Code Available (3191)
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.
Additional Manufacturer Narrative
Corrections to d10/h3.The reported event that drill bit ø2.5x125mm ao fitting was alleged of 'component/device stuck' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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.

• Brand Name: DRILL BIT Ø2.5X125MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8287414
• Report Number: 0008031020-2019-00055
• Device Sequence Number: 16577765
• Product Code: LXH
• UDI-Device Identifier: 04546540368973
• UDI-Public: 04546540368973
• 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: Health Professional
• Device Catalogue Number: 700347
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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