MAUDE Adverse Event Report: RESOLVE SURGICAL TECHNOLOGIES ATTACHMENT BIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	391.883
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery with the cable tensioner.First, the knob of the cable tensioner did not turn when the tension was being put on.After cutting the cable and washing the cable tensioner with physiological saline, the knob could be turned.Next, using a new cable, the tension was applied to the cable tensioner.Then locked the tension holder and the tension was released by reverse-rotating the knob, but the cable tensioner could not be removed from the tension holder.The surgery was completed successfully within thirty (30) minutes delay.No further information is available.This report is for one (1) attachment bit.This is report 7 of 7 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery with the cable tensioner.First, the knob of the cable tensioner did not turn when the tension was being put on.After cutting the cable and washing the cable tensioner with physiological saline, the knob could be turned.Next, using a new cable, the tension was applied to the cable tensioner.Then locked the tension holder and the tension was released by reverse-rotating the knob, but the cable tensioner could not be removed from the tension holder.The surgery was completed successfully within thirty (30) minutes delay.No further information is available.This report is for one (1) attachment bit.This is report 7 of 7 for complaint (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.H10 additional narrative: d10: date of concomitant therapy is (b)(6) 2021.G2 h3, h4, h6: part: 391.883.Lot: p031515.Manufacturing site: selzach.Release to warehouse date: august 29, 2008.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to us customer quality (cq) for evaluation.The us cq team forwarded the device to the supplier resolve surgical for investigation.Visual analysis of the returned sample revealed no issues with the attachm-bit f/tension holder.No new additional information can be added after reviewing received files.The dimensional inspection was not performed due to the design of the device and inaccessibility of the internal components without the destruction of the device.The cannulation was verified to be clear by passing a cable through the device.The device was also able to attach and detach to the mating part with no issues.The device passed this functional check.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the attachm-bit f/tension holder as the device functioned as intended.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 drawings reflecting the current and manufactured revisions were reviewed: attachment bit orthopaedic cable system.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: ATTACHMENT BIT
• 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: 13266024
• Report Number: 1833824-2022-00008
• Device Sequence Number: 13878444
• Product Code: LXH
• UDI-Device Identifier: 07611819719842
• UDI-Public: (01)07611819719842
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: 391.883
• Device Lot Number: P031515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2021
• Supplement Date Received by Manufacturer: 01/18/2022; 01/10/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 01/18/2022; 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2008
• 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: CABLE TENSIONER; PROVISIONAL TENSIONING DEVICE; TENSION HOLDER F/TEMP-USE; UNK - CABLE/WIRE
• Patient Sex: Unknown