MAUDE Adverse Event Report: SYNTHES GMBH 11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.144S

Device Problem Break (1069)

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

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

T was reported that on an unknown date, the patient underwent a removal procedure for a broken tfna nail.This report involves one (1) tfna nail.This is report 1 of 1 for (b)(4).

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: d4, g1, h3, h4, h6: part 04.037.144s, lot 97p3029: manufacturing location: monument.Manufacturing date: march 31, 2021.Expiration date: march 01, 2031.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: a photo investigation was completed: visual analysis of the provided photo revealed a tfna nail construct with a nail, a blade and screw visible at the bone with signs of bone fracture and the nail appear to have broken at the femur right.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 confirmed.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 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: manufacturing location: monument manufacturing date: 31 march 2021 expiration date: 01 march 2031 part: 04.037.144s, 11mm/130 deg ti cann tfna 235mm/right-sterile lot: 97p3029 (sterile) production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection 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.Sterilization control number (scn) supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part: 04.037.912.3, tfna lock drive lot: 83p2587 production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part: 04.037.912.4, wave spring, shim ended lot: 77p1340 production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley were reviewed and determined to be conforming.Part: 04.037.942.2, lock prong, 130 degree tfna lot: 92p4292 production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Part: 21127, timoagri16.00 lot: 45p3578 inspection instruction met all inspection acceptance criteria.Certificate of test supplied by ati specialty metals was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.¿ visual analysis of the returned sample revealed that the tfna fem nail ø11 r 130° l235 timo15 has broken in two fragments, the broken fragments were returned.No other problem was reported.A dimensional inspection was not performed for the tfna fem nail ø11 r 130° l235 timo15 due to the design of the device.¿as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.¿ ¿the overall complaint was confirmed as the observed condition of the tfna fem nail ø11 r 130° l235 timo15 would contribute to the complained device issue.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.¿ drawing/specifications reviewed? current and manufactured revisions were reviewed.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: 11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13921285
• MDR Text Key: 293165672
• Report Number: 8030965-2022-01939
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650527
• UDI-Public: (01)07611819650527
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.144S
• Device Lot Number: 97P3029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø11 R 130° L235 TIMO15; TFNA HELICAL BLADE PERF L90 TAN
• Patient Outcome(s): Required Intervention