MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PL COLLAR 8 H/93; PLATE, FIXATION, BONE

Model Number	241.381
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, during post-op event surgeon notified that he is going to remove hardware from a distal tibial.The removal of the hardware was extraordinarily difficult and involved a lot of improvisation to remove the broken screws.All of the hardware was successfully removed except some small shards of two broken screws left behind after the over-mill was run over them.The reason for the removal was an infected non union.The original surgery was done on (b)(6) 2021.It appears that the screws were broken pre-operatively, but not noticed on pre-op xrays.There is no further information.This report is for one (1)lcp one-third tubular pl collar 8 h/93.This is report 2 of 10 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary : the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that there was no damage or defects with the lcp one-third tubular pl collar 8 h/93.However; there is clearly a significant amount of infected bone.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for lcp one-third tubular pl collar 8 h/93.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : part # 241.381 synthes lot # h454326 supplier lot # n/a release to warehouse date: 25 sep 2017 manufactured by: synthes monument.No ncrs were generated during production.Device history review : review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.H10: correction narrative: b1, h6: it was reported in the initial report that the lcp one-third tubular pl collar 8 h/93 plate device broke.However, upon complaint review, it was determined that the plate device did not break; and therefore, there was no reported product problem.The health effect - impact code and medical device problem code have been updated accordingly.

• Brand Name: LCP ONE-THIRD TUBULAR PL COLLAR 8 H/93
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15141869
• Report Number: 2939274-2022-03052
• Device Sequence Number: 17554336
• Product Code: HRS
• UDI-Device Identifier: 10886982166913
• UDI-Public: (01)10886982166913
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 241.381
• Device Catalogue Number: 241.381
• Device Lot Number: H454326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 91 KG