MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE XL, STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72202683
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip of the device was misaligned.When soft tissue pierced, it got stuck and could not come off due to the misaligned issue.As per customer report, no patient injury was reported.Procedure was finished with the same device.
Additional Manufacturer Narrative
One 72202683 extra long arthropierce instrument returned.This has been identified as a one year old reusable instrument.The complaint stated: "it was reported that tip of the device was misaligned.When soft tissue pierced, it got stuck and could not come off due to the misaligned issue." the instrument's jaw shares the same centerline as the shaft and handle.The shaft is straight and aligned.No obvious bows or twists were observed.Inner tip and outer shaft distal tip are tangent and the area between does not exceed 0.003" drawing note criteria.There was no damage or twist of the pierce tip.The surface is smooth with no catches, nicks or burrs felt.The instrument does not snag a surgical glove.The scissor handle function is with free articulation and no binding, grit felt.The instrument is very good condition and presented no mechanical fault.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: ARTHROPIERCE XL, STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield; MA 02048
• MDR Report Key: 7795970
• Report Number: 1219602-2018-01087
• Device Sequence Number: 14134763
• Product Code: LXH
• UDI-Device Identifier: 03596010651457
• UDI-Public: (01)03596010651457(10)50680284
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2018

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 Model Number: 72202683
• Device Catalogue Number: 72202683
• Device Lot Number: 50680284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 09/25/2018; 10/30/2018
• Initial Report FDA Received Date: 08/18/2018
• Supplement Report FDA Received Date: 09/28/2018; 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1