MAUDE Adverse Event Report: SYNTHES GMBH LAMINA SPREADER; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number 389.265

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

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 history lot: part number: 389.265, lot number: t105414, manufacturing site: (b)(4), release to warehouse date: 14-jul-2014.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Part number: 389.265, lot number: t105414, manufacturing site: (b)(4), release to warehouse date: 14-jul-2014.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the leaf spring had snapped during inspection.No patient involvement.This report is for one (1) lamina spreader.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- the device was not returned.A photo-investigation was performed upon inspecting the image provided, the leaf spring on the lamina spreader was observed to be broken.The complaint is confirmed.However, the root cause for the reported event cannot be determined from the available information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: part number: 389.265; lot number: t105414; manufacturing site: tuttlingen; release to warehouse date: 14-jul-2014.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.,part number: 389.265; lot number: t105414; manufacturing site: tuttlingen; release to warehouse date: 14-jul-2014.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12238142
• MDR Text Key: 266408856
• Report Number: 8030965-2021-06134
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 07611819741959
• UDI-Public: (01)07611819741959
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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: 389.265
• Device Lot Number: T105414
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/02/2021
• Patient Sequence Number: 1