MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS

Model Number 03.100.025

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was 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.

Event Description

It was reported that on an unknown date, the pelvic reduction forceps for screws 3.5mm was found broken in the sterile processing department.The device broke at the pivoting point where the two separate pieces join.There was no patient involvement.This report is for 1 low profile pelvic system red forceps used w/3.5mm screws.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, h4, h6: part 03.100.025, lot t927558: manufacturing site: tuttlingen.Release to warehouse date: october 30, 2008.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Review of raw material certificate could not be established during this review due to the age of the device (over 12 years old).H3, h6: a product investigation was completed: upon visual inspection, the device was the connector was broken and not returned which has caused the complaint condition.There was slight rust observed on the device but have no impact on the device functionality.No dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition is confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11031251
• MDR Text Key: 222310539
• Report Number: 2939274-2020-05639
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982070746
• UDI-Public: (01)10886982070746
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

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 Model Number: 03.100.025
• Device Catalogue Number: 03.100.025
• Device Lot Number: T927558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1