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

Model Number	241.381
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of postoperative pain development is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.Patient code (b)(4) used to capture additional medical/surgical intervention required.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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.
Event or Problem Description
It was reported that a patient underwent a hardware removal due to pain on (b)(6) 2018.During the procedure, the following devices were removed; (1) lcp one-third tubular plate with collar 8 holes, (5) 2.7 mm cortical screws, (3) 2.5 mm cortical screws, (3) 2.0 mm cancellous screws.It was unknown if there were broken fragments generated from the device and it was unknown if there was a surgical delay.Patient outcome was unknown.This report is for one (1) lcp one-third tubular plate with collar 8 holes/93mm.This is report 1 of 4 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.B5, d6: unknown date approximately one year prior to the (b)(6) 2018 removal.H3, h4, h6: part 241.381, lot 9983838: manufacture date: january 18, 2016.Manufacturing location: elmira.A review of the device history record (dhr) revealed no complaint related anomalies.The device history record shows this lot of lcp one-third tubular plate with collar 8 holes/93mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.
Event or Problem Description
The patient had an ankle open reduction internal fixation (orif), and implantation of plate at the lateral malleolus and screws at the medial malleolus on unknown date, approximately one year prior to the (b)(6) 2018 removal.During the removal procedure, the following devices were removed one (1) lcp one-third tubular plate, three (3) 2.7 cortex screw, three (3) 3.5 cortex screw, and two (2) 4.0 cancellous screws.It was noted, there was no surgical delay during the revision procedure.An arthrex suture anchor was implanted after the removal of the other hardware.The procedure was successfully completed.The patient outcome was unknown.
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.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.
Event or Problem Description
The hardware removal procedure was performed on (b)(6) 2018 and not on july 16, 2018 as reported in initial medwatch.
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.Part: 241.381; lot: 9983838; part manufacture date: january 18, 2016, manufacturing location: elmira; part expiration date: n/a; nonconformance noted: n/a dhr record review: a review of the device history record (dhr) revealed no complaint related anomalies.The device history record shows this lot of lcp one-third tubular plate with collar 8 holes/93mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7733321
• Report Number: 2939274-2018-53123
• Device Sequence Number: 13850046
• Product Code: HRS
• UDI-Device Identifier: 10886982166913
• UDI-Public: (01)10886982166913
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/13/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 241.381
• Device Catalogue Number: 241.381
• Device Lot Number: 9983838
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 07/31/2018; 09/06/2018; 09/10/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/24/2018; 09/07/2018; 09/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention