MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RETRACTOR BLADE 50MM CRANIAL/CAUDAL-LEFT

Model Number	03.615.350
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
Reporter is a synthes employee.Part number: 03.615.350, lot number: t951371.Manufacturing site: tuttlingen.Release to warehouse date: 29-oct-2010.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the blade cranial/caudal le l50 (p/n: 03.615.350, lot number: t951371) was received at us customer quality (cq).Visual inspection of the complaint device showed a small piece had broken off one of the corners.Device failure/defect identified? yes.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.This complaint is confirmed as a small piece had broken off one of the corners.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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that the instrument tip was damaged.This was noticed when the sets were opened to be used for surgery.It had no patient impact as is was not the size the surgeon needed to use.This report is for one (1) retractor blade 50mm cranial/caudal-left.This is report 1 of 1 for (b)(4).

• Brand Name: RETRACTOR BLADE 50MM CRANIAL/CAUDAL-LEFT
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11555890
• Report Number: 2939274-2021-01488
• Device Sequence Number: 17194459
• Product Code: GAD
• UDI-Device Identifier: 10705034715759
• UDI-Public: 10705034715759
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 03.615.350
• Device Catalogue Number: 03.615.350
• Device Lot Number: T951371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1