MAUDE Adverse Event Report: ARTHREX, INC. PNCH, WB XL 15U, 2.75 W/FLUSHPORT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	PNCH, WB XL 15U, 2.75 W/FLUSHPORT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The precise cause for a missing tip pin could not be determined.Tip pin was not returned along with complaint device.Unable to perform function testing due to the related condition.
Event or Problem Description
It was reported that during an arthroscopic surgery the pin at the jaw of the punch broke off.The surgeon was able to retrieve the device out of the patient.There was no harm for the patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The precise cause for a missing tip pin could not be determined.Tip pin was not returned along with complaint device.Unable to perform function testing due to the related condition.

• Brand Name: PNCH, WB XL 15U, 2.75 W/FLUSHPORT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11274676
• Report Number: 1220246-2021-02535
• Device Sequence Number: 1166884
• Product Code: MDM
• UDI-Device Identifier: 00888867270886
• UDI-Public: 00888867270886
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 02/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PNCH, WB XL 15U, 2.75 W/FLUSHPORT
• Device Catalogue Number: AR-11240XLF
• Device Lot Number: 10431291
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other