MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RETRACTOR BODY

Model Number 03.816.001

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.A product investigation was conducted.Visual inspection: the retractor body (p/n: 03.816.001, lot #:l926807) was returned and received at us cq.Upon visual inspection, it was observed that the one of the generic pin (zyl_sti_d_x_5.8mm) was received disassemble due to which the screw sleeve and screw angulation blade assembly was fell apart from the left retractor arm and missing a clip component.The screw angulation blade was observed to be broken and the broken fragments were not returned.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed yes, the device received was broken and fell apart.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the retractor body (p/n: 03.816.001, lot #:l926807).A service and repair evaluation was not performed as the device was non-repairable.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.A device history record (dhr) review was conducted: part: 03.816.001; lot: l926807.Manufacturing site: (b)(4); release to warehouse date: 08.January 2019.A manufacturing record evaluation 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

It was reported that during evaluation at service, and repair it was found out that the retractor body component was damaged, it won't stay on the device.There was no patient involvement.During manufacturer's investigation of the returned device it was noticed that the one of the generic pin (zyl_sti_d_x_5.8mm) was received disassemble due to which the screw sleeve and screw angulation blade assembly was fell apart from the left retractor arm and missing a clip component.The screw angulation blade was observed to be broken and the broken fragments were not returned.This product condition was re-evaluated and determined to be reportable on october 23, 2020.This report is for one (1) retractor body this is report 1 of 1 for (b)(4).

• Brand Name: RETRACTOR BODY
• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10764394
• MDR Text Key: 213945948
• Report Number: 2939274-2020-04911
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034730622
• UDI-Public: (01)10705034730622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.816.001
• Device Catalogue Number: 03.816.001
• Device Lot Number: L926807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2019
• 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