MAUDE Adverse Event Report: SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.242S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional 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: h3, h4, h6: manufacturing location: monument release to warehouse date: 27-nov-2022.Expiration date: 31-oct-2032.Part number: 04.037.242s, 12mm/130 deg ti cann tfna 170mm¿ sterile.Lot number#: 3096p55 (sterile).Production 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 (bent).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.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 ¿insertion handle detaching¿.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 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 12/130 deg ti cann tfna 170 - sterile was observed stripped and worn at the nail connection.No other issue was identified.A dimensional inspection for the 12/130 deg ti cann tfna 170 sterile was not performed, due to post manufacturing damaged.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 12/130 deg ti cann tfna 170 sterile 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.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 or Problem Description
It was reported that on (b)(6) 2023, during a hip fracture case utilizing.The tfna system, the tfna nail became detached from the insertion handle, while the resident surgeon was implanting.The nail was removed using the proper extraction device.The attending surgeon deemed the nail ¿defective¿ and requested a new tfna nail be opened and utilized.Case completed without further complications.No surgical delay.No patient consequence.This report involves one (1) 12mm/130 deg ti cann tfna 170mm - sterile.This is report 2 of 2 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 170MM - STERILE
• Common Device Name: 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: 17080951
• Report Number: 8030965-2023-07224
• Device Sequence Number: 2188109
• Product Code: HSB
• UDI-Device Identifier: 10886982097262
• UDI-Public: 10886982097262
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: 04.037.242S
• Device Catalogue Number: 04.037.242S
• Device Lot Number: 3096P55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL INSERTION HANDLES
• Patient Sex: Unknown