MAUDE Adverse Event Report: RESOLVE SURGICAL TECHNOLOGIES CABLE TENSIONER WITH PISTOL GRIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.221.015
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes reports an event in usa as follows: it was reported that on february 10, 2022, an unknown surgical procedure was performed for unknown reason.The tensioner does not hold tension.The procedure was completed successfully without surgical delay.There was no patient consequence reported.This complaint involves one(1) device cable tensioner with pistol grip.This is report 1 of 1 for complaint pc-(b)(4).

• Brand Name: CABLE TENSIONER WITH PISTOL GRIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): RESOLVE SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13720398
• Report Number: 1833824-2022-00014
• Device Sequence Number: 11885811
• Product Code: LXH
• UDI-Device Identifier: 10886982076748
• UDI-Public: (01)10886982076748
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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: 03.221.015
• Device Catalogue Number: 03.221.015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown