MAUDE Adverse Event Report: SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.244S

Device Problem Fracture (1260)

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

Event Type  Death  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported a patient who had a trochanteric fixation nail advanced (tfna) had a fractured.A revision surgery occurred.Original implant date was (b)(6) 2021.Explant date was (b)(6) 2022.Patient deceased post revision surgery.This is report 1 of 1 for (b)(4).This report is for a tfna nail.

Manufacturer Narrative

Additional narrative: unknown when fracture occurred.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 history: part #: 04.037.244s; lot #: 57p0049.Manufacturing site: (b)(6).Supplier: (b)(6).Release to warehouse date: (b)(6) 2020.Expiration date: 01 may 2030.No code available is for injury, revision surgery and death.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

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.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 nail body of tfna fem nail ø12 r 130° l235 timo15 has broken in two pieces, the broken fragments was returned.No other problems was reported.A dimensional inspection was not performed for the tfna fem nail ø12 r 130° l235 timo15 post-manufacturing 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 as the observed condition of the tfna fem nail ø12 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: yes, no issues.¿dimensional inspection: n/a.Device history part #: 04.037.244s, lot #: 57p0049, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 20 may 2020, expiration date: 01 may 2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: d2: additional procode: ktt.G4 h6: 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 nail body of tfna fem nail ø12 r 130° l235 timo15 has broken in two pieces, the broken fragments was returned.No other problems was reported.Visual analysis of the received x-rays determined it is not possible to completely dissociate the death of the patient from the device as there was no information reported on other medical conditions contributing to mortality and a definitive diagnosis of fracture non-union was not provided although this is likely given that the nail itself broke.Given the patient¿s age, and the relatively high rate of patient mortality surrounding hip fracture surgery, as opposed to elective hip surgery, and given that it is likely there was a fracture non-union that contributed to the nail breakage and this can be suggestive of underlying poor health and/or mobility, it is likely that there were other pre-existing medical causes that contributed significantly to the patient¿s demise.Nevertheless, in the absence of this information it is not possible to dissociate the device from the cause of death.This conclusion was obtained by the analysis of chief safety officer.A dimensional inspection was not performed for the tfna fem nail ø12 r 130° l235 timo15 post-manufacturing 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 as the observed condition of the tfna fem nail ø12 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.D10: date of concomitant therapy is (b)(6) 2021.

• Brand Name: 12MM/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): WERK SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14218869
• MDR Text Key: 290163564
• Report Number: 8030965-2022-02733
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651241
• UDI-Public: (01)07611819651241
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.244S
• Device Lot Number: 57P0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Death
• Patient Sex: Female
• Patient Weight: 74 KG