MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100; PIN, FIXATION, SMOOTH

Model Number	IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/10/2020
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 not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the k-wire was punctured through the package and injured the nurse.Due to this event, the device became unsterile.The surgery was successfully finished with a new device with the same part number.It was not necessary to switch the surgical technique or perform a second surgery.Surgery performed was a pip arthrodesis.Update 14-jul-2020: following update received: the wire has a protection cap which was perforated.The sterile package itself was intact and the devices inside of the package were sterile when opening the outer package.The nurse had a minor stab wound that bled a little.He could continue to work and has no additional complaints.
Additional Manufacturer Narrative
The reported event and packaging allegation cannot be confirmed upon investigation of the returned product.Visual evaluation identified no apparent malfunction relating to the drill pins.The kit was received without any of its original packaging, and therefore, the as-received condition of the device cannot be confirmed.Additionally, the picture provided by the customer cannot confirm the packaging allegation or the reported event, as no breach in the sterile barrier can be found.The root cause of the reported failure mode is undetermined.However, the most likely cause is improper handling of the device.

• Brand Name: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10332220
• Report Number: 1220246-2020-01973
• Device Sequence Number: 19770402
• Product Code: HTY
• UDI-Device Identifier: 00888867032811
• UDI-Public: 00888867032811
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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 Expiration Date: 09/30/2021
• Device Model Number: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Device Catalogue Number: AR-4152DS
• Device Lot Number: 10396945
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other