MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TFNA 235MM/LEFT STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.015S

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing date: january 11, 2020.Expiration date: december 1, 2029.Part number: 04.037.015s, 10mm/125 deg ti cann tfna 235mm/left ¿ sterile.Lot number: 33p9535 (sterile).Lot quantity: 5.One piece was scrapped after a tool 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) lmd was reviewed and determined to be conforming.Labels clearly indicate ¿left¿ nail.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual, sterilization 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 ¿surgeon inserted left nail into patient with right fracture¿ does not indicate breakage of the nail or any of its components.Therefore, a 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.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation (orif) surgery for right femoral trochanteric fractures with the tfna system.During the surgery, based on the surgeon¿s instruction, the tfna nail in question was prepared, the tfna nail was for the left.Without knowing that the tfna nail was for the left, the tfna nail for left was inserted to the patient with right femoral trochanteric fractures.The surgery was completed.Later that same day the issue was noticed.The surgeon commented that he did not see any problems at this time, and follow-up is needed.Concomitant device reported: tfna helical blade (part number unknown, lot unknown, quantity 1), tfna end cap (part number unknown, lot unknown, quantity 1), locking screw (part number unknown, lot unknown, quantity 1).This report involves one (1) 10mm/125 deg ti cann tfna 235mm/left ¿ sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 10MM/125 DEG TI CANN TFNA 235MM/LEFT STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10212285
• MDR Text Key: 197792651
• Report Number: 8030965-2020-04553
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649491
• UDI-Public: (01)07611819649491
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.015S
• Device Lot Number: 33P9535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 78 YR