MAUDE Adverse Event Report: ARTHREX, INC. PUNCH WDBITRXL 15°UP 2.75MM15°CRVD SFT; ACCESSORIES, ARTHROSCOPIC

Model Number	PUNCH WDBITRXL 15°UP 2.75MM15°CRVD SFT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.The hand instrument device has a missing tip pin.Standard function test could not be performed due to it's related condition.At this time the cause of the event remained undetermined.
Event or Problem Description
The device was received by arthrex (b)(4) from the customer with a note that stated ¿dull¿.No additional information as to what failure mode occurred was provided.No adverse conditions reported for patient, operator or third party.Update 06-aug-2019: the device ar-11241xl was investigated by arthrex (b)(4).The investigation showed that the tip of the device is missing.Arthrex (b)(4) contacted the customer to verify if the broken tip was retrieved from the patient or if the broken tip remained inside the patient.It was not possible for the customer to confirm if the tip was retrieved or not.

• Brand Name: PUNCH WDBITRXL 15°UP 2.75MM15°CRVD SFT
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8930535
• Report Number: 1220246-2019-01271
• Device Sequence Number: 19340121
• Product Code: NBH
• UDI-Device Identifier: 00888867003057
• UDI-Public: 00888867003057
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: PUNCH WDBITRXL 15°UP 2.75MM15°CRVD SFT
• Device Catalogue Number: AR-11241XL
• Device Lot Number: 57868
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other