MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ALUMINUM SPOON RETRACTOR LARGE

Model Number	03.100.112
Medical Device Problem Codes	Crack (1135); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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) aluminum spoon retractor large this is report 8 of 10 for complaint (b)(4).
Additional 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.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.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: ALUMINUM SPOON RETRACTOR LARGE
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12938860
• Report Number: 2939274-2021-06973
• Device Sequence Number: 5085379
• Product Code: GAD
• UDI-Device Identifier: 10886982071101
• UDI-Public: (01)10886982071101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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: 03.100.112
• Device Catalogue Number: 03.100.112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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 MEDIUM; MALLEABLE RETRACTOR 20MM WIDE; MALLEABLE RETRACTOR 30MM WIDE; MALLEABLE RETRACTOR 40MM WIDE
• Patient Sex: Unknown