MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRL TP PASSING PN PK6 2.7MX15; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	014485
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction surgery, when positioning, the drill got broken inside the patient's anatomy.Back-up device was used to complete the surgery.No patient injuries or significant delay reported.Some broken pieces were removed with pliers, however, as per reporter response not all the pieces were removed.
Additional Manufacturer Narrative
One 2.7mm drill tipped passing pin was returned for evaluation.Visual assessment of the device confirmed the reported breakage.Approximately, 750 inches of the distal end (drill tip) of the passing pin has been broken off and was not returned for examination.The passing pin is also scored along its length and shows signs of metal debridement.The condition of the device indicates that during placement or over drilling the passing pin became bent causing it to come in contact with the drill guide or drill resulting in the observed damage and breakage.Drilling with or over a bent passing pin would require the use of excessive force.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¿.The impact to the patient is the retained non-implantable fragment of the externally communicating device, possible local irritation and/or discomfort, and additional radiological imaging/exposure cannot be completely ruled out.

• Brand Name: DRL TP PASSING PN PK6 2.7MX15
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8788751
• Report Number: 1219602-2019-00811
• Device Sequence Number: 2102935
• Product Code: HWE
• UDI-Device Identifier: 03596010025869
• UDI-Public: 03596010025869
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 014485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1