MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL ORTHOCORD VIOLET/BLUE W/NDLES *PK/12; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	223114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Unspecified Tissue Injury (4559)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: d4, h4: the lot number was unknown; therefore, the expiration date and device manufacture date were unknown.Investigation summary = > the complaint device was not returned to j&j medtech orthopaedics, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated a j&j medtech orthopaedics product failure(s).Multiple attempts were done to obtain more information from the author; however, no response was received.It is unknown if complaints derived from this journal article were previously reported and documented in the j&j medtech orthopaedics complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.Based on the current available information, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: cao y, gao s, cui z, fu y, bai l, si g, fan j, lv y, zhou f.Comparison of different immobilisation durations following open surgery for acute achilles tendon rupture: a prospective cohort study.J orthop surg res.2024 aug 21;19(1):497.Doi: 10.1186/s13018-024-04970-y.Pmid: 39169350; pmcid: pmc11337624.Objective/methods/study data: the aim of this prospective cohort study was to compare different immobilisation durations in order to determine the optimal duration after open surgery for achilles tendon rupture (atr) repair.Between march 2019 to may 2023, a total of 1088 patients (1063 male and 25 female; mean age, 35.0 years, range, 18¿60 years) who underwent open surgery for acute atr repair were included in the study.The patients were categorised into four groups (a, b, c, and d) according to postoperative immobilisation durations of 0, 2, 4, and 6 weeks, respectively.All patients received the same suture technique using the krackow locking loop technique with two w4843 (ethibond of johnson & johnson, us) nonabsorbable sutures and the modified kessler suture technique with two ref223114 (orthocord of depuy synthes, us) nonabsorbable suture, and a similar rehabilitation protocol after brace removal.They were clinically examined at 2, 4, 6, 8, 10, 12, 14, and 16 weeks postoperatively, with a final follow-up at a mean of 19.0 months.Catalog number was available for the suspected depuy synthes device possibly associated with reported adverse events: ref223114 - orthocord other devices that were used on the patient at the time of the event: ethicon ethibond (w4843) adverse event(s) and provided interventions possibly associated with orthocord product code 223114 (qty 38): (n=20) re-rupture occurred at 8 weeks after surgery and was diagnosed through clinical examination and a positive thompson¿s test.All patients had recovered at the last follow-up.(n=18) superficial infections; all patients had recovered at the last follow-up.A copy of this literature article is attached to this medwatch report.

• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20505940
• Report Number: 1221934-2024-03771
• Device Sequence Number: 8209898
• Product Code: NEW
• UDI-Device Identifier: 10886705008841
• UDI-Public: (01)10886705008841(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,User Facility
• 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 Catalogue Number: 223114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown