MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MALLEABLE RETRACTOR 40MM WIDE

Model Number 03.100.017

Device Problems Crack (1135); Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Initial reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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

It was reported that on an unknown date, unable to sterilize/assemble the malleable retractor.Chipping and cracking on instruments.Unable to use.This complaint involves ten(10) devices.This report is for (1) malleable retractor 40mm wide.This is report 3 of 10 for complaint (b)(4).

• Brand Name: MALLEABLE RETRACTOR 40MM WIDE
• 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 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12937531
• MDR Text Key: 286650808
• Report Number: 2939274-2021-06967
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10886982070661
• UDI-Public: (01)10886982070661
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.100.017
• Device Catalogue Number: 03.100.017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALUM HOHMANN RETRACTOR 8 SHT NARROW TIP; ALUMINUM BLUNT PELVIC RETRACTOR; ALUMINUM HOHMANN RETRACTOR 18MM WIDTH; ALUMINUM HOHMANN RETRACTOR 22MM WIDE TIP; ALUMINUM HOHMANN RETRACTOR 35MM WIDTH; ALUMINUM SPOON RETRACTOR LARGE; ALUMINUM SPOON RETRACTOR MEDIUM; MALLEABLE RETRACTOR 20MM WIDE; MALLEABLE RETRACTOR 30MM WIDE