MAUDE Adverse Event Report: SYNTHES GMBH 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.013.656S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 10/03/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, the patient had a nonunion from a previous surgery, so this was a revision surgery.Previous rafn nail and screws were removed.Removal was uneventful, and successful.No further information is available.This report involves one 12mm ti cann retro/antegrade femoral nail-ex/380mm-sterile.This is report 7 of 9 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.Additional device product codes: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 04.013.656s synthes lot # h269895 supplier lot # n/a release to warehouse date: 11 jan 2017 manufactured by: synthes monument no ncrs were generated during production.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that there was no damage or defects with the 12 ti cann retro/antegrade fem nl/380-s.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 not confirmed as the 12 ti cann retro/antegrade fem nl/380-s was found to have no damage or defects.No definitive root cause could be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15666598
• MDR Text Key: 302349006
• Report Number: 8030965-2022-08850
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982088222
• UDI-Public: 10886982088222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.013.656S
• Device Catalogue Number: 04.013.656S
• Device Lot Number: H269895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS; TI ENCP T40 SD 0 EXT RET FEM NL SPRL BLD; TI SPIRAL BLD 70 FOR TI RETRO FEM NL-EX
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male