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

Catalog Number	03.615.460
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 le l60 (part number 03.615.360, lot unknown, quantity 1).This report involves one (1) retractor blade 60mm cranial/caudal-right.This is report 2 of 2 for (b)(4).
Event or Problem Description
Concomitant device reported: blade cranial/caudal le l60 (part number 03.615.360, lot t951375, quantity 1).
Additional 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.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-RIGHT
• Common Device Name: RETRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11101272
• Report Number: 8030965-2020-10072
• Device Sequence Number: 3785650
• Product Code: GAD
• UDI-Device Identifier: 07611819399990
• UDI-Public: (01)07611819399990
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.615.460
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLADE CRANIAL/CAUDAL LE L60; BLADE CRANIAL/CAUDAL LE L60