MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDING MECHANISM; FORCEPS

Model Number 314.291

Device Problem Break (1069)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 Description

It was reported that on (b)(6) 2020, the sliding mechanism broke when adding tension to the device.The surgeon was trying to reduce the fracture of a distal femur.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.This report involves one (1) sliding mechanism.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.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.H10: additional narrative: h3, h4, h6: part 314.291, lot 11-7600: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: august 08, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a photo investigation was completed: the instrument was not returned, and the investigation will be completed based on the supplied image.The image was reviewed, and the complaint condition of broken was confirmed as the image showed handle being broken.As the instrument was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was performed, and no issues were noted.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: SLIDING MECHANISM
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11012020
• MDR Text Key: 221557188
• Report Number: 2939274-2020-05581
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982188779
• UDI-Public: (01)10886982188779
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

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: 314.291
• Device Catalogue Number: 314.291
• Device Lot Number: 11-7600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 01/12/2021
• Supplement Dates FDA Received: 01/11/2021; 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1