MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: 3.5 MM LCP MEDIAL PROXIMAL TIBIA PLATE/SCREWS; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Product complaint #:(b)(4).This report is for an unk - constructs: lcp/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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.

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing fracture fixation or osteotomy of the proximal tibia.Failed fracture fixation or osteotomy of the proximal tibia has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 540 patients had subsequent surgery within 12 months after the index surgery for an additional fracture repair surgery or hardware removal procedure in the proximal tibia.24 patients had nonunion within 12 months post-surgery.194 patients had malunion within 12 months post-surgery.This is for depuy synthes 3.5 mm lcp proximal tibia plate/screws constructs, 4.5 mm/5.0 mm lcp proximal tibia plate/screws constructs, 3.5 mm lcp medial proximal tibia plate/screws constructs, 4.5 mm/5.0 mm lcp medial proximal tibia plate/screws constructs, 3.5 mm lcp posterior medial proximal tibia plate/screws constructs, 4.5 mm/5.0 mm lcp proximal lateral tibia plate/screws constructs, and 3.5 mm va-lcp proximal tibia plate/screws constructs.This report is for (1) unk - constructs: lcp.This report is 17 of 18 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.H10 additional narrative: d1: updated impacted product information h3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The 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: UNK - CONSTRUCTS: 3.5 MM LCP MEDIAL PROXIMAL TIBIA PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12256376
• MDR Text Key: 264805232
• Report Number: 2939274-2021-04411
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention