MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LAMINA SPREADER; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number 389.265

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(b)(4).Part returned.The device was received, the investigation could not be completed, and no conclusion could be drawn, a review of the device history records has been requested and is currently pending completion as product is entering the complaint system.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 on (b)(6) 2021, the lamina spreader was discovered to be broken during reconfiguration of a kit in sterile processing department.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) lamina spreader.This report is 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.H3, h6: part number: 389.265.Lot number: a7qa04 (wo#: (b)(4).Manufacturing site: tuttlingen.Release to warehouse date: 30-jan-2007.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 14 years old).Visual inspection: the lamina spreader (p/n: 389.265, lot number: a7qa04 ) was received at us customer quality (cq).Visual inspection of the complaint device showed the leaf spring had broken.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the leaf spring had broken.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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: LAMINA SPREADER
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11820966
• MDR Text Key: 253207925
• Report Number: 2939274-2021-02351
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034775203
• UDI-Public: (01)10705034775203
• 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
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 389.265
• Device Catalogue Number: 389.265
• Device Lot Number: A7QA04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1