MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC K-WIRE 1.6MM; PIN, FIXATION, SMOOTH

Catalog Number 71161016

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2020

Event Type  Injury  

Event Description

It was reported that, during an orif of left humerus, the surgeon pinned a plate to the humerus with a peri-loc k-wire to verify its placement with x-ray imaging.Upon removal of the wire, the tip of it broke and remained inside the patient.It is unknown whether surgery was delayed or not.The patient outcome is unknown.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.According to clinical/medical investigation, the case reports a broken peri-loc k-wire tip that was retained in the patient.Although it was noted that x-rays were taken during the procedure, no x-ray images or clinically relevant supporting documentation was provided for inclusion in this medical investigation.Based on the limited information provided the root cause for the reported breakage could not be determined.The material of the k wire tip is 17-4 ph stainless steel and long-term implantation data is not available.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.No further medical assessment can be rendered at this time.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will not be issued for the device.

• Brand Name: PERI-LOC K-WIRE 1.6MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10064201
• MDR Text Key: 191237635
• Report Number: 1020279-2020-01765
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 03596010179708
• UDI-Public: 3596010179708
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71161016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 53