MAUDE Adverse Event Report: SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 200MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.113S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing location: monument.Manufacturing date: 03-dec-2020.Expiration date: 01-nov-2030.Part number: 04.037.113s, 11mm/125 deg ti cann tfna 200mm - sterile.Lot number: 79p4564 (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 (b)(4) 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 ¿blade was inserted incorrect direction through the nail¿ 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent a open reduction internal fixation surgery for a trochanteric femur fracture.During the surgery, the nail became slightly tight in the intrathecal space because it did not match the shape of the patient's bone, but the surgeon inserted the nail.The surgeon reinserted the guidewire many times during blade insertion, but it was not corrected by the anterior approach.The surgery was completed successfully without any surgical delay.On (b)(6) 2021, the surgeon found that the blade was inserted in the incorrect direction through a nail.The surgeon performed both intraoperative and postoperative x-rays, but he wasn¿t aware of it.The surgeon predicted that this event was occurred when he reinserted the guide wire.The revision surgery was performed on (b)(6) 2021 to remove all implants and replace them with new ones.Concomitant device reported: unk - insertion instruments: (part# unknown; lot# unknown; quantity: 1).Tfna end cap extens.0 tan (part# 04.038.000s), lot# 198p191, qty 1).Lockscr ø5 l34 f/nails tan light green (part# 04.005.524s, lot# 8l23832, qty 1).This report is for one (1) 11mm/125 deg ti cann tfna 200mm - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/125 DEG TI CANN TFNA 200MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12699523
• MDR Text Key: 284697254
• Report Number: 8030965-2021-09008
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.113S
• Device Lot Number: 79P4564
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Patient Sequence Number: 1
• Treatment: TFNA HELICAL BLADE PERF L85 TAN; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Age: 87 YR
• Patient Weight: 50