MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP PROXIMAL TIBIA PLATE 14 HOLES/262MM-RIGHT; PLATE, FIXATION, BONE

Model Number	240.046
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A review of the device history records has been requested.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.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent hardware removal due to infection.During procedure, the plates had to be cut away to remove the screws.All implants were removed successfully.However, there was difficulty removing the fragments that were generated from the broken devices and trephine was used to remove the screw head.No other device was use before using the trephine.Original implantation was on (b)(6) 2015, for an open reduction and internal fixation (orif) of the proximal tibia.The procedure was completed successfully.There was no surgical delay.The patient outcome was stable.This report addresses the intra-op event of the difficulty removing the screw, while (b)(4) will capture post op event that involves the infection/one broken screw.This report is for one (1) 4.5mm lcp proximal tibia plate.This is report 2 of 2 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.Device history records.Part mfg date: 26-dec-2012.Part exp.Date: n/a.Manufacturing location: depuy synthes: elmira.Lot number: 7138154.Part number: 240.046.Dhr record review: a review of the device history record (dhr) revealed no non-conformances.The dhr shows lot#: 7138154 of 4.5mm lcp proximal tibia plate 14 holes/262mm-right was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This 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.Device history batch null, device history review: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.

• Brand Name: 4.5MM LCP PROXIMAL TIBIA PLATE 14 HOLES/262MM-RIGHT
• 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: 8201970
• Report Number: 2939274-2018-55619
• Device Sequence Number: 223205
• Product Code: HRS
• UDI-Device Identifier: 10886982164636
• UDI-Public: (01)10886982164636
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 240.046
• Device Catalogue Number: 240.046
• Device Lot Number: 7138154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 72