MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 14 HOLES/206MM/RIGHT; PLATE, FIXATION, BONE

Catalog Number 04.124.220

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Synthes lot # 18p2758.Supplier lot # n/a.Supplier batch # 10l3218.Release to warehouse date: 10oct2019.Supplier: jabil-monument.No ncr's were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Complaint is confirmed as we are able to confirm complaint description, as it is visible that one plate has 16 holes instead of 14, based on the received pictures.Jabil nonconformance will investigate this complaint.The root cause was traced to manufacturing error.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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

Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that the locking compression plate (lcp) was shorter than the normal size.It was not used in a procedure.This report is for one (1) 3.5mm ti lcp proximal tibia pl low bend 14 holes/206mm/right.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

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.H10: additional narrative: h3, h4, h6: part 04.124.220, lot 18p2758: release to warehouse date: october 10, 2019.Supplier: (b)(4).No non-conformance reports (ncr's) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: complaint is confirmed as we are able to confirm complaint description, as it is visible that one plate has 16 holes instead of 14, based on the received pictures.The root cause was traced to manufacturing error.Relevant actions have been taken to address the issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: 3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 14 HOLES/206MM/RIGHT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11261041
• MDR Text Key: 230243924
• Report Number: 8030965-2021-00758
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K030597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.124.220
• Device Lot Number: 18P2758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 03/01/2021; 03/16/2021
• Supplement Dates FDA Received: 03/01/2021; 04/01/2021
• Patient Sequence Number: 1