MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PIN PASSING DRILL TIP 2.4X381MM STRL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7208678

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

International zip code: (b)(6).

Event Description

It was reported that during a crossed anterior knee ligament surgery, a pin passing drill broke when it was passed through a tibial and femoral bone; steel threads with a loop to allow passage of the bone suture threads.It is unknown if there was a backup device available.The surgery had a delay of 2 hours due to the metal debridement of the joint.The device had to be removed from the knee with open surgery.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: the reported 2.4 x 381mm drill tipped passing pin, used in treatment, was returned for evaluation.Visual assessment of the device confirmed the reported breakage.Approximately 5 inches of the distal end (drill tip) has been broken off.Examination of the break area shows an excessive amount of material has been displaced.The passing pin is bent.The passing pin is also scored in multiple places along its length.The passing pins condition indicates it was subjected to excessive forces during use resulting in its failure.Per the device instructions for use under ¿precautions¿ as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in failure.A review of the manufacturing and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

H3, h6: the reported 2.4x381mm drill tipped passing pins, used in treatment, have not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the passing pins broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the passing pin during use.Bending the passing pin during placement.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Correccion in e1.

• Brand Name: PIN PASSING DRILL TIP 2.4X381MM STRL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9535714
• MDR Text Key: 174181457
• Report Number: 1219602-2019-01701
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 03596010591265
• UDI-Public: 03596010591265
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7208678
• Device Catalogue Number: 7208678
• Device Lot Number: 2036794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR