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

Model Number 03.615.350

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

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 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
• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; SZ 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11555890
• MDR Text Key: 244708770
• Report Number: 2939274-2021-01488
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034715759
• UDI-Public: 10705034715759
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1