MAUDE Adverse Event Report: ARTHREX, INC. BIRDBEAK, 2.75MM, 22 DEGREE UP TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BIRDBEAK, 2.75MM, 22 DEGREE UP TIP
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
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 after use in a rotator cuff repair procedure the ar-11890 bird beak device was returned to the distributor office.Upon return to the distributor it was noticed that the device had a broken tip.The missing piece was small and was not noticed as missing at the time of procedure, therefore no attempt was made to retrieve it.
Additional Manufacturer Narrative
The broken point 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.

• Brand Name: BIRDBEAK, 2.75MM, 22 DEGREE UP TIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7901745
• Report Number: 1220246-2018-00659
• Device Sequence Number: 11150927
• Product Code: LXH
• UDI-Device Identifier: 00888867003774
• UDI-Public: 00888867003774
• 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): 11/30/2018

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, 2.75MM, 22 DEGREE UP TIP
• Device Catalogue Number: AR-11890
• Device Lot Number: 82176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• 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: 11/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other