MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 200MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.043S

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) reports an event as follows: it was reported that on an unknown date before the nail insertion, the set screw was stuck.The set screw was turned clockwise and anticlockwise and could not turn.Another screw was used to complete the procedure successfully with no delay.Concomitant device reported: unk - insertion instruments: trauma (part# unknown; lot# unknown; quantity: 1).This report is for one (1) 10mm/130 deg ti cann tfna 200mm - sterile.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: manufacturing location: monument manufacturing date: april 27, 2021 expiration date: april 01, 2031 part: 04.037.043s, 10mm/130 deg ti cann tfna 200mm ¿ sterile lot: 134p148 (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 (albuquerque) 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: 87p2816 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: 77p1357 production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by smalley were reviewed and it was noted that the lot number referenced on the material certificate does not match the lot number on the quality history card.Data recorded on the quality history card was reviewed and determined to be conforming.Part: 04.037.942.2, lock prong, 130 degree, tfna lot: 83p6797 production order traveler met all inspection acceptance criteria.Part: 21127, timoagri16.00 bp80 lot: 59p0325 inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company 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.Visual inspection: the complaint devices tfna fem nail ø10 130° l200 timo15 was returned to customer quality (cq) west chester for investigation along with the end cap.The tfna nail had endcap locked onto it.No other issues were identified.Functional test: a functional test to remove the endcap from the nail was performed.The end cap was found jammed/seized onto the nail and could not be removed even after several tries.Hence, the items failed the functional test.Dimensional inspection: complaint relevant dimension cannot be measured as the two items have gotten stuck together and the device history record (dhr) review confirmed that there were no issues identified on the parts during manufacturing.Document/specification review: based on the date of manufacture, the current and manufactured version of drawing were reviewed.-ti cannulated trochanteric fixation nail-advanced conclusion: the tfna end cap was stuck on the tfna nail and the two items could not be separated.Hence, the complaint was confirmed.A definitive assignable root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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.H5.

• Brand Name: 10MM/130 DEG TI CANN TFNA 200MM - 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12673652
• MDR Text Key: 277725944
• Report Number: 8030965-2021-08862
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K131548
• 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
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.043S
• Device Lot Number: 134P148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - INSERTION INSTRUMENTS: TRAUMA