MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PEDIATRIC LCP HIP PLATE 2.7MM/130°/2 HOLES; PLATE,FIXATION,BONE

Catalog Number 02.108.303

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Unknown date in 2019.This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.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.(b)(4).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

It was reported that on an unknown date in 2019, the patient underwent a bilateral corrective osteotomy case, the health care professional requested the consultant bring one (1) unknown plate.The first plate was inserted with no issue.Upon inserting the second plate, the incorrect angle was used and the surgeon had to change out the plate for another unknown plate.This error resulted in an unknown delay in surgery.Procedure and patient outcome were unknown.Concomitant device reported: unk - screws: trauma (part# unknown; lot# unknown; quantity unknown); unk - plate: trauma (part# unknown; lot# unknown; quantity unknown).This report is for one (1) plates.This is report 1 of 1 for (b)(4).

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.Date of event reported as an unknown date in (b)(6) 2019.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.

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.Awareness date reported on follow up 1 report as april 01, 2019 but should have been may 10, 2019.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.

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.Updated event description.Additional device product codes: hwc, jds.Complainant part is not expected to be returned for manufacturer review/investigation.Date rec¿d by mfr : the incorrect date was inadvertently utilized in initial medwatch.The correct date is april 13, 2019.  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

It was reported that on an unknown date, the patient underwent a bilateral corrective osteotomy case, the health care professional requested the consultant to bring two (2) different 2.7mm angled plates (110 degree bend & 130 degree bend).The first plate (110 degree angle) was inserted with no issues, upon inserting the second pediatric locking compression hip plate (130 degree bend), the health care professional indicated that the second plate was in incorrect angle and subsequently had to change out the second plate for another 110 degree angled plate.This error resulted in a 15 minutes surgical delay.Procedure completed successfully.Patient outcome is unknown.Concomitant device reported: screws (part# unknown; lot# unknown; quantity unknown).This report is for one (1) pediatric lcp hip plate 2.7mm/130°/2 holes.

• Brand Name: PEDIATRIC LCP HIP PLATE 2.7MM/130°/2 HOLES
• 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: 8564768
• MDR Text Key: 143551714
• Report Number: 2939274-2019-57730
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K112085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.108.303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2019
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention