MAUDE Adverse Event Report: RESOLVE SURGICAL TECHNOLOGIES 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE, FIXATION

Model Number	02.120.601S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in great britain as follows: patient sustained periprosthetic fracture (ppf) below femoral nail in (b)(6) and was fixed with va condylar plate on an unknown date in (b)(6) 2022.Patient was readmitted approximately 3 months after implant with plate fracture.No new trauma.Had been mobilizing in residential home.Normal to low bmi.Fracture non-united, but no evidence of infection.Revision occurred (b)(6) 2022.This is report 5 of 11 for (b)(4).This report is for a cable with crimp.This complaint is linked to (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.Date of event: unknown between (b)(6) 2022 and (b)(6) 2022.Implant date unknown date in (b)(6) 2022.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.Investigation summary the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that the cercl-cable w/crimp ø1.7 sst had no signs of issue or defect.X-ray evidence provided shows a plate and screw construct at the left distal femur with signs of bone and plate breakage.No other issues were identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.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 cercl-cable w/crimp ø1.7 sst.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.Device history: part #: 298.801.01s, lot #: 8l96020, manufacturing site: (b)(4), release to warehouse date: 11 jan2022, expiration date: 01 jan2032, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part #: 298.801.01.Non-sterile lot #: p404455.Manufacturing site: (b)(4), release to warehouse date: 21 oct2021, supplier: (b)(4).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: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): RESOLVE SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15076469
• Report Number: 1833824-2022-00058
• Device Sequence Number: 17339624
• Product Code: JDQ
• UDI-Device Identifier: 10886982040091
• UDI-Public: (01)10886982040091
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.120.601S
• Device Catalogue Number: 298.801.01S
• Device Lot Number: 8L96020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; LOCKING ATTACHMENT PLATE 3.5 F/LCP 4.5/5; VA LOCKSCR Ø5 SELF-TAP L36 SST; VA LOCKSCR Ø5 SELF-TAP L38 SST; VA LOCKSCR Ø5 SELF-TAP L60 SST; VA LOCKSCR Ø5 SELF-TAP L65 SST; VA LOCKSCR Ø5 SELF-TAP L75 SST; VA PERIPROSTHETIC LOCK SCREW Ø5 SELF-TAP; VA-LCP CONDYLAR PLATE 4.5/5.0 LE 12HO L2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female