MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 90MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.290S

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(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 history lot: manufacturing location: (b)(4) / packaged, sterilized and released by: (b)(4).Release to warehouse date: june 8, 2020.Expiration date: may 1, 2030.Part number: 04.038.290s, tfna helical blade 90mm -sterile lot number: 57p7431 (sterile) note: helical blade was manufactured by (b)(4); lot number 57p0989.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lmd rev ac 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 (b)(4) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review 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.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 surgery with the blade in question.On an unknown date, the surgeon confirmed that the cut-out occurred, and the blade was inserted more proximal position than the proper position.On october 16, the patient underwent the revision surgery and in the revision the blade was removed and re-inserted at the proper position.No further information is available.Concomitant device reported: tfna nail (part# 04.037.242s, lot# 46p1538, quantity 1), locking screw (part# 04.005.526s, lot# 7l05589, quantity 1), unknown end cap (part# unknown, lot# unknown, quantity 1).This report is for one (1) tfna helical blade 90mm sterile.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 90MM 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: 10819222
• MDR Text Key: 217942288
• Report Number: 8030965-2020-08829
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652446
• UDI-Public: (01)07611819652446
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131548
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.290S
• Device Lot Number: 57P7431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1