MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSRT H&LE FOR EXPERT NL/100; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.010.486
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown date in 2021.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 or Problem Description
It was reported that on an unknown date, one (1) radiolucent standard insertion handle, one (1) depth gauge for 2.0mm and 2.4mm cortex screws, and one (1) driving cap/threaded were broken due to the amount of use.No were fragments generated.It is unknown if there was a surgical delay.The procedure successfully completed.There was a patient consequence.This report is for one (1) radiolucent insrt h&le for expert nl/100.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.Visual inspection: the insert-handle radioluc l100 (p/n: 03.010.486, lot # 9200414) was received at us cq.Upon visual inspection, it was observed the broken tip of the mating driving cap f/insertion handle (p/n: 03.010.523, lot # 8953342) was retained in the threaded portion of the insertion handle.No issues were observed with the device.No, the received condition of the device did not agree with the complaint description and was not confirmed as no fractures/breaks were observed on the returned device.The mating device the driving cap f/insertion handle (p/n: 03.010.523, lot # 8953342) was observed to be broken and will be investigated.Conclusion: the complaint condition was not confirmed as no damage were observed on the insert-handle radioluc l100 (p/n: 03.010.486, lot # 9200414).There is no indication that a design or manufacturing issue were identified.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.010.486.Lot: 9200414.Manufacturing site: hagendorf.Supplier: n/a.Release to warehouse date: 20 january 2015.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot 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.

• Brand Name: RADIOLUCENT INSRT H&LE FOR EXPERT NL/100
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12561072
• Report Number: 2939274-2021-05860
• Device Sequence Number: 1296404
• Product Code: LXH
• UDI-Device Identifier: 10886982069047
• UDI-Public: (01)10886982069047
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 03.010.486
• Device Catalogue Number: 03.010.486
• Device Lot Number: 9200414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DRIVING CAP/THREADED; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DRIVING CAP/THREADED