MAUDE Adverse Event Report: ARTHREX, INC. BIRDBEAK PENETRATOR, 2.75MM, STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BIRDBEAK PENETRATOR, 2.75MM, STRAIGHT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that upon inspection of the bird beak, it was found to have a broken tip.This was noticed at the distributor office.The device was last used in a rcr procedure.No attempt was made to retrieve the broken fragment as it was too small to be noticed.
Additional Manufacturer Narrative
The broken point related condition is typically caused by dropping the device or the tip of the device is forced against bone while trying to pass the device through tissue.Unrelated, device also has a bent shaft.
Event or Problem Description
It was reported that upon inspection of the bird beak, it was found to have a broken tip.This was noticed at the distributor office.The device was last used in a rcr procedure.No attempt was made to retrieve the broken fragment as it was too small to be noticed.Updated information obtained nov.7, 2018: upon receipt of the complaint device it was discovered that the original lot number reported (lot 82809) was incorrect.The correct lot number of the complaint device which was returned to arthrex is lot 13239.

• Brand Name: BIRDBEAK PENETRATOR, 2.75MM, STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7901807
• Report Number: 1220246-2018-00660
• Device Sequence Number: 1395160
• Product Code: LXH
• UDI-Device Identifier: 00888867003729
• UDI-Public: 00888867003729
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BIRDBEAK PENETRATOR, 2.75MM, STRAIGHT
• Device Catalogue Number: AR-11880
• Device Lot Number: 13239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other