MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - ZIPFIX IMPLANTS; CERCLAGE FIXATION

Device Problem Migration (4003)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Unknown event date.This report is for an unknown zipfix implants/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.Without a lot number the device history records review could not be completed.Product was not returned.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 Description

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 9,687 patients who underwent surgery with depuy synthes sternal zipfix system from january 1, 2011, to june 30, 2020.Of these patients, 8,790 (6119 male and 2671 female; mean age of 65 years) had a 12 months post-index surgery continuous participation in premier healthcare database.The following complications have been identified as per icd 9 & 10 code: 134 patients had subsequent surgery with a primary and secondary diagnosis within 0-12 months following the index procedure due to the following reasons: t81.4xxa infection following procedure n=36 (26.9%).T81.32xa disruption of internal operation (surgical) wound, nec n=29 (21.6%).998.59 postoperative infection, nec n=27 (20.1%).Y83.8 other surgical procedures as the cause of abnormal reaction of the patient n=16 (11.9%).998.31 disruption of internal operation (surgical) wound n=13 (9.7%).730.28 osteomyelitis, other specific site n=11 (8.2%).T81.31xa disruption of external operation (surgical) wound, nec n=10 (7.5%).519.2 mediatinitis n=8 (6.0%).998.83 non-healing surgical wound n=8 (6.0%).998.32 disruption of external operation surgical wound n=7 (5.2%).M86.9 osteomyelitis, unspecified n=7 (5.2%).T81.89xa surgical operation causing reaction, nec n=7 (5.2%).E878.8 surgical operation causing reaction nec n=6 (4.5%).J98.51 mediastinitis n=6 (4.5%).T81.30xa disruption of wound unspecified n=6 (4.5%).682.2 cellulitis/abscess, trunk n=5 (3.7%).A41.01 sepsis due to (b)(6) n=5 (3.7%).L02.213 cutaneous abscess of chest wall n=5 (3.7%).L03.313 cellulitis of chest wall n=5 (3.7%).T85.79xa infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts n=5 (3.7%).995.92 systemic inflammatory response syndrome (sirs) due to severe sepsis n=4 (3.0%).996.78 complication, other internal orthopedic device n=4 (3.0%).E878.1 artificial implant causing reaction n=4 (3.0%).T84.84xa pain due to internal orthopedic prosthetic devices, implants n=4 (3.0%).038.9 septicemia nos n=3 (2.2%).995.91 systemic inflammatory response syndrome (sirs) due to sepsis n=3 (2.2%).998.11 hemorrhage complicating a procedure n=3 (2.2%).998.89 surgical complications, nec n=3 (2.2%).M86.18 other acute osteomyelitis, other site n=3 (2.2%).S22.20xa unspecified fracture of sternum, initial encounter for closed fracture n=3 (2.2%).Z47.2 encounter for removal of internal fixation device n=3 (2.2%).790.7 bacteremia n=2 (1.5%).A41.02 sepsis due to (b)(6) n=2 (1.5%).A41.1 sepsis due to other specified (b)(6) n=2 (1.5%).A41.9 sepsis, unspecified organism n=2 (1.5%).T81.83xa persistent postprocedural fistula, initial encounter n=2 (1.5%).T84.89xa other specified complication of internal orthopedic prosthetic devices, initial encounter n= 2 (1.5%).T85.848a pain due to other internal prosthetic devices, implants and grafts, initial encounter n=2 (1.5%).Y83.1 surgical operation with implant of artificial internal device as the cause of abnormal reaction of the patient n=2 (1.5%).038.0 streptococcal septicemia n=1 (0.7%).038.11 (b)(6) septicemia n=1 (0.7%).038.12 septicemia due to (b)(6) n=1 (0.7%).038.49 septicemia, gram-negative organism nec n=1 (0.7%).513.1 abscess of mediastinum n=1 (0.7%).730.08 acute osteomyelitis, other specific site n=1 (0.7%).730.18 chronic osteomyelitis, other specific site n=1 (0.7%).730.98 infection of bone nos, other specified sites n=1 (0.7%).733.82 nonunion of fracture n=1 (0.7%).996.49 mechanical complication of other internal orthopedic device, implant, and graft nec n=1 (0.7%).996.59 malfunction of other device/graft n=1 (0.7%).996.79 complications of internal prosthetic device nec n=1 (0.7%).998.12 hematoma complicating a procedure n=1 (0.7%).A41.2 sepsis due to unspecified staphylococcus n=1 (0.7%).A41.50 gram-negative sepsis unspecified n=1 (0.7%).A41.81 sepsis due to enterococcus n=1 (0.7%).E878.4 restorative surgery causing reaction n=1 (0.7%).E879.8 procedure causing reactions nec n=1 (0.7%).J85.3 abscess of mediastinum n=1 (0.7%).M86.10 other acute osteomyelitis unspecified site n=1 (0.7%).M86.68 other chronic osteomyelitis, other site n=1 (0.7%).M86.8x8 other osteomyelitis, other site n=1 (0.7%).M96.840 postprocedural hematoma of a musculoskeletal structure following a musculoskeletal system procedure n=1 (0.7%).R65.10 systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction n=1 (0.7%).S21.109a unspecified open wound of unspecified front wall of thorax without penetration into thoracic cavity, initial encounter n=1 (0.7%).T81.32xd disruption of internal operation (surgical) wound, nec, subsequent encounter n=1 (0.7%).T81.4xxd infection following a procedure, subsequent encounter n=1 (0.7%).T84.218a breakdown (mechanical) of internal fixation device of other bones, initial encounter n=1 (0.7%).T84.69xa infection and inflammatory reaction due to internal fixation device of other site, initial encounter n=1 (0.7%).T85.628a displacement of internal prosthetic devices, implants and grafts, initial encounter n=1 (0.7%).T85.84xa pain due to internal prosthetic devices, implants and grafts, initial encounter n=1 (0.7%).T85.89xa other complication of internal prosthetic devices, implants and grafts, nec, initial encounter n=1 (0.7%).V54.01 removal of internal fixation device n=1 (0.7%).Y79.3 surgical instruments, orthopedic devices with adverse incidents n=1 (0.7%).Y83.9 surgical procedure, unspecified as the cause of abnormal reaction of the patient n=1 (0.7%).709 patients had infection within 0-12 months following the index procedure.6 patients had nonunion within 0-12 months following the index procedure.This report is 1 of 2 for (b)(4).This is for unknown depuy synthes sternal zipfix system.

• Brand Name: UNK - ZIPFIX IMPLANTS
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14219714
• MDR Text Key: 290167911
• Report Number: 2939274-2022-01503
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention