MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.045S

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent an unknown surgery for the trochanteric fracture of the femur with the tfna in question.The patient complained about minor pain after the surgery.The surgeon suspected by x-rays that the tfna was broken on an unknown date.The surgeon removed it and the patient underwent the bipolar hip arthroplasty on (b)(6) 2021.No further information is available.This report is for one (1) 10mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

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.H3, h6: a product investigation was conducted.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 tfna fem nail ø10 le 130° l235 timo15 (p/n: 04.037.045s, lot #: 3l21053) broke from the nail body.A dimensional inspection was performed for the tfna fem nail ø10 le 130° l235 timo15 (p/n: 04.037.045s, lot #: 3l21053) was unable to be performed due to post manufacture damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed yes as the observed condition of the tfna fem nail ø10 le 130° l235 timo15 (p/n: 04.037.045s, lot #: 3l21053) 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.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 17-may-2019, part number: 04.037.045s, 10mm/130 deg ti cann tfna 235mm/left ¿ sterile, lot number: 3l21053 (sterile) , lot quantity: (b)(4).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 parts reviewed: part number: 04.037.942.2, lock prong, 130 degree lot number: 4l03046 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended lot number: h761697 lot quantity: (b)(4).Work 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 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive lot number: h853433 lot quantity: (b)(4).One piece was scrapped in cell, final inspection, for a damaged thread.Work order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, met all inspection acceptance criteria apart from the one piece noted.Part number: 21127, timoagri16.00 bp80 lot number: h856706 lot quantity: (b)(4) lbs.Certified test report was reviewed and determined to be conforming.Lot summary report dated 15-mar-2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.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.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: 10MM/130 DEG TI CANN TFNA 235MM/LEFT - 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: 13289220
• MDR Text Key: 284014363
• Report Number: 8030965-2022-00394
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649972
• UDI-Public: (01)07611819649972
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.045S
• Device Lot Number: 3L21053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• 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 END CAP EXTENS. 0 TAN; TFNA HELICAL BLADE PERF L80 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female