MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE PIN TRO PT 1.3 X140; PLATE, FIXATION, BONE

Catalog Number	128047
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery 2 wires were broken while being removed.A delay less than 30 minutes was reported.Backup available.No injury or impact to patient reported yet.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned that the anthology inserter fractured at the tip, most likely from impact.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.A fracture can also be the result of multiple impacts.This fracture caused the instrument to become inoperable.The fractured off portion was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaint for the listed batch.A clinical analysis indicated that no clinical supporting documents were provided to conduct a thorough assessment of the reported infection.Should additional information be provided, the clinical/medical investigation task will be reopened.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
The associated devices and single packaging was returned and evaluated.It was reported that during surgery 2 wires were broken while being removed.A visual examination of the returned pins and opened packaging indicated no obvious damage to the 4 of 6 pins that were received.The two broken pins were not returned nor were any photos provided that would have assisted in the evaluation.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with any released batch number.Although it cannot be confirmed without the return of the damaged devices, there are several potential factors that are unrelated to the manufacture and design of the device that could lead to breakage.Some of those are procedural/user error, traumatic injury, use of improperly sized devices or over use of the device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened and reevaluated.We consider this investigation closed.
Additional Manufacturer Narrative
The associated devices and single packaging was returned and evaluated.It was reported that during surgery 2 wires were broken while being removed.A visual examination of the returned pins and opened packaging indicated no obvious damage to the 4 of 6 pins that were returned.The two broken pins were not returned and no photos were provided.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.The quality team was made aware of this complaint.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GUIDE PIN TRO PT 1.3 X140
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8208240
• Report Number: 1020279-2019-00003
• Device Sequence Number: 277092
• Product Code: HRS
• UDI-Device Identifier: 03596010082565
• UDI-Public: 03596010082565
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/22/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 128047
• Device Lot Number: 18DK00045
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 12/10/2018; 12/10/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 03/21/2019; 04/03/2019; 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1