MAUDE Adverse Event Report: SYNTHES GMBH 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE; FEMUR NAIL, STERILE

Catalog Number 04.037.158S

Device Problem Break (1069)

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

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 2 for (b)(4).It was reported by the customer that during an unknown surgery on (b)(6) 2022, it was observed that while removing the broken nail, the surgeon proceeded to give it a hammer and the chuck twisted.It was unknown if and how the procedure was completed.The status of the patient was unknown.No additional information was provided.This report is for one (1) tfna fem nail ø11 r 130° l380 timo15 device.

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.H6: manufacturing location: monument, manufacturing date: october 14, 2020, expiration date: october 01, 2030, part: 04.037.158s, 11mm/130 deg ti cann tfna 380mm/right- sterile, lot: 73p5581 (sterile).One piece was scrapped at gundrill after a tooling breakage.Production order traveler met all inspection acceptance criteria apart from the one piece noted.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.Sterilization control number (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: part: 04.037.912.3, tfna lock drive, lot: 72p2523, production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part: 04.037.912.4, wave spring, shim ended, lot: 52p7554.Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Corrected material certification and certificate of conformance and quality history card received from smalley were reviewed and determined to be conforming.Part: 04.037.942.2, lock prong, 130 degree tfna, lot: 30p7150.Production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Part: 21127, timoagri16.00, lot: 50p3768.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.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 380MM/RIGHT - STERILE
• Type of Device: FEMUR NAIL, STERILE
• 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: 14119579
• MDR Text Key: 289349319
• Report Number: 8030965-2022-02462
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

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: 04.037.158S
• Device Lot Number: 73P5581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNIV-CHUCK W/T-HANDLE; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female