MAUDE Adverse Event Report: SYNTHES GMBH RETRACTOR BLADE 60MM CRANIAL/CAUDAL-LEFT

Catalog Number 03.615.360

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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

Device report from synthes reports an event in the (b)(6) as follows: it was reported that an unknown date, after a procedure, it was noticed that part of the retractor blade was broken.The patient was sent for x-rays a day after the procedure and no fragments were visible in the x-ray.The procedure was completed successfully.Concomitant devices reported: blade cranial/caudal r l60 ( part number 03.615.460, lot unknown, quantity 1).This report involves one (1) retractor blade 60mm cranial/caudal-left.This is report 1 of 2 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: a product investigation was conducted.Visual inspection: the received blade is broken as complained.One portion of the distal side wall is broken off.Besides, the instrument presents normal signs of use with slight discoloration of the coating.Dimensional inspection: the dimensions were checked at the time of manufacturing and passed inspection requirements with no non-conformities noted.Document/specification review: relevant drawing was reviewed during this investigation.This blade was manufactured in november 2010 according to the specifications.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material aluminium alloy (al 7075) was according to the specification of the device.Summary: the complaint condition is confirmed as one portion of the distal side wall is broken off.This production lot conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The correct material was used.There were no issues during the manufacture of this product that would contribute to this complaint condition.Considering the age of this instrument ¿ this blade is now 10 years old - a manufacturing related issue can be excluded.A definitive root cause for the breaking could not be determined based on the provided information.However, we do suppose that the device encountered unintended forces, such as excessive force application during its use, which finally resulted in the breakage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part number: 03.615.360, lot number: t951375, manufacturing site: tuttlingen, release to warehouse date: 05-nov-2010.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: RETRACTOR BLADE 60MM CRANIAL/CAUDAL-LEFT
• Type of Device: RETRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11101208
• MDR Text Key: 224566706
• Report Number: 8030965-2020-10071
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 07611819399914
• UDI-Public: (01)07611819399914
• 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: 12/05/2020

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 Catalogue Number: 03.615.360
• Device Lot Number: T951375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/05/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLADE CRANIAL/CAUDAL R L60; BLADE CRANIAL/CAUDAL R L60