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

Catalog Number 298.801.01S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.No code available is for re-fracture, injury, revision surgery.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 history: part # 298.801.01s, lot # 6l08742, release to warehouse date: 04 sep 2019, expiration date: 01 sep 2029, supplier: (b)(4).Non-sterile, part # 298.801.01, lot # p345713, release to warehouse date: 28 aug 2019, manufacturer: (b)(4).A manufacturing record evaluation was performed for the non-sterile 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported a revision of a stem, right side, occurred due to the implant fracturing.The patient had a miss-step while walking which caused her to stumble.The implant then fractured.As a result of the stem fracturing, this caused the proximal femur to fracture.This distal part of the stem was extremely well fixed and was very difficult to remove.The proximal part of the stem and body was easy to remove as this part of the femur was fractured causing it to become loose.This patient has had a number of previous revisions.To my knowledge this is the history: primary cemented stem with cup.Lima, not depuy.They had a revision at (b)(6) hospital in (b)(6) 2020, no information.They then had a periprosthetic fracture where the lima stem was removed an the reclaim was implanted with a hook plate and cables (depuy) and a 40mm +5 ceramic head (depuy).(b)(6) 2020.They must have had another revision as some stage to remove our 40+5 ceramic head because when we did the revision there was no 40mm depuy head and in-situ, and there was a lima dual mobility head and liner with the lima cup already in-situ.I'm unsure when this occurred.It may have been linked to number 3.As above.The hook plate and cables were also removed at some stage too.This pc was linked to (b)(4) and was created to capture the ceramic head revision as stated in the event description.This is report 2 of 4 for (b)(4).This report is for a cable with crimp.

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.D6b 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
• Type of Device: 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: 14288148
• MDR Text Key: 290785661
• Report Number: 1833824-2022-00039
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819719927
• UDI-Public: (01)07611819719927
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 298.801.01S
• Device Lot Number: 6L08742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 05/08/2022
• Supplement Dates FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; LCP PROXFEM HOOKPL 4.5/5 SHAFT 4HO L169; LOCKSCR Ø5 SELF-TAP L14 SST; LOCKSCR Ø5 SELF-TAP L14 SST; POSITION-PIN 4.5 F/LCP SST; POSITION-PIN 4.5 F/LCP SST
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female