MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFRAME INSULATED TABLE CLAMP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	387.346
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the synframe insulated table clamp (p/n: 387.346, lot #: 3148034) was returned and received at us cq.Upon visual inspection, the holding clip component was observed to be jammed.The distal threads were not visible to examine but could have been damaged which could have caused the jammed condition, so the overall complaint condition was confirmed.There were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Investigation conclusion: the complaint condition was confirmed for the synframe insulated table clamp (p/n: 387.346, lot #: 3148034) as the holding clip was jammed which could be due to internal threads damage.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: 387.346, lot: 3148034, manufacturing site: (b)(4), release to warehouse date: 24.July 2009, 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 or Problem Description
It was reported that on an unknown date, during inspection of the equipment, it was found that threaded portion of screw shank to a nut is stuck and threads are damaged.There was no patient or procedure involvement.During manufacturer's investigation of the returned device it was observed that the holding clip component was jammed.This report is for 1 synframe insulated table clamp.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SYNFRAME INSULATED TABLE CLAMP
• 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: 11872659
• Report Number: 2939274-2021-02536
• Device Sequence Number: 14270099
• Product Code: LXH
• UDI-Device Identifier: 10705034771120
• UDI-Public: (01)10705034771120
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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: 387.346
• Device Catalogue Number: 387.346
• Device Lot Number: 3148034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1