MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 85MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.385S

Device Problem Migration (4003)

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

Event Type  Injury  

Event Description

Device report from synthes reports an event in the (b)(6) as follows: it was reported tfna helical blade cut out in a patient who was operated on at (b)(6) hospital.The cut out was found 2 weeks post operatively.This is 1 of 3 tfna cut outs.This complaint involves one (1) device unk - nail head elements: tfna helical blade.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: 510k: this report is for an unk - nail head elements: tfna helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter is a j&j sales representative.(b)(4).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.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.

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.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 for one (1) tfna fenestrated helical blade 85mm - sterile.

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: h4 device history: manufacturing location: elmira / packaged, sterilized and released by: monument, manufacturing date: 22-sep-2021, expiration date: 01-sep-2031, part number: 04.038.385s, tfna fenestrated helical blade 85mm -sterile, lot number: 387p093 (sterile), lot quantity: (b)(4).Note: helical blade was manufactured by elmira; lot numbers: 352p513 quantity 48 and 352p522 quantity (b)(4).Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 20672 supplied by sterigenics was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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: TFNA FENESTRATED HELICAL BLADE 85MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14136685
• MDR Text Key: 289450587
• Report Number: 2939274-2022-01340
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652569
• UDI-Public: (01)07611819652569
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.385S
• Device Lot Number: 387P093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 12/130 DEG TI CANN TFNA 235/LEFT - SILE.; 5.0 TI LCKNG SCREW T25 SD 38 F/IM NAIL-S.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female