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

Catalog Number	391.201
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: a device history record (dhr) review was conducted: the product was returned to us cq and sent to rti surgical for evaluation.The rti surgical team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no defects were identified with cable tensioner.The dimensional inspection was not performed due to alleged complaint condition.The cable tensioner was tested as per the supplier specification wi-eng-004.The tensioner failed the calibration test with the following tension measurements: 36.6 kg, 35.2 kg & 34.6 kg.Thus device failed to function as intended.The observed condition in the device was consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the cable tensioner.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.Drawing/specifications reviewed? the following drawing reflecting the current and manufacture revision was reviewed.Device history lot - part #: 391.201, synthes lot#: p228673, supplier lot #: p228673, released to warehouse: 23dec2015, supplier: (b)(4).No ncrs were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 (b)(6) as follows: it was reported that, the patient underwent an open reduction internal fixation surgery for the femoral diaphyseal fracture with cable tensioner in question.During the procedure, the surgeon passes the cable through the plate and applied tension with the cable tensioner which can be applied tension up to 50kg.However, when he applied 20 kg of tension, the knob of the tensioner did not turn and move forward.When the surgeon tried to apply tension many times, there was a feeling that something clogging was gone, and he was finally able to proceed with the cable tensioner.Procedure was completed successfully with thirty(30) minutes of surgical delay.Concomitant device reported: unk - cable/wire: (part# unknown; lot# unknown; quality:1).This report is for one (1) cable tensioner.This is report 1 of 1 for complaint (b)(4).

• Brand Name: CABLE TENSIONER
• 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: 13581281
• Report Number: 1833824-2022-00013
• Device Sequence Number: 4673707
• Product Code: LXH
• UDI-Device Identifier: 07611819719811
• UDI-Public: (01)07611819719811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: 391.201
• Device Lot Number: P228673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTACHM-BIT F/TENSION HOLDER; TENSION HOLDER F/TEMP-USE; UNK - CABLE/WIRE; UNK - PLATES: TRAUMA
• Patient Sex: Unknown