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

Catalog Number 04.037.145S

Device Problem Migration (4003)

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

Event Date 01/26/2022

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that a patient was implanted with a trochanteric fixation nail-advanced (tfna) system on (b)(6) 2022 to treat the pertrochanteric femoral fracture.On (b)(6) 2022 the surgeon noticed a cut-out of tfna.Nails and blade are loose.Surgeon informed that the blade was statically locked.The revision surgery was planned on (b)(6) 2022.No further information provided.This report is for one (1) 11mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A device history record (dhr) review was conducted: manufacturing location: (b)(4).Manufacturing date: 14-jul-2021.Expiration date: 01-jul-2031.Part number: 04.037.145s, 11mm/130 deg ti cann tfna 235mm/left-sterile.Lot number: 269p906 (sterile).Lot quantity: 6.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.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: component parts were not reviewed as the reported complaint condition of ¿cut-out of tfna; nail and blade are loose¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d6b, d9 h3, h4, h6: part 04.037.145s, lot 269p906: manufacturing location: monument.Manufacturing date: july 14, 2021.Expiration date: july 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 product investigation was completed: visual analysis of the provided photo revealed that a nail, a blade and screw construct was visible at the bone with signs of bone fracture and the nail appear to be the original position at the femur left.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 nail was observed with discoloration, and some scratched on the surface.There are marks inside the transversal hole and the lock prong feature of the internal locking mechanics is missing in the evidence provided.A functional test was unable to be performed due to lock prong was not received.The complaint condition was not able to be replicated.The relevant drawings were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the device would not 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.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/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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13500646
• MDR Text Key: 288835439
• Report Number: 8030965-2022-00791
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650534
• UDI-Public: (01)07611819650534
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.145S
• Device Lot Number: 269P906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; TFNA HELICAL BLADE PERF L100 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR