MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.145S

Device Problems Migration or Expulsion of Device (1395); 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.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.(b)(4).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 in (b)(6) 2020 it was noticed that the femoral neck component moved out laterally even though it was locked statically.The patient was successfully treated with a trochanteric fixation nail advanced (tfna) set.Concomitant devices: tfna end cap (part# 04.038.000s, lot# 32p3118, quantity 1); locking screw (part# 04.005.526s, lot# unknown, quantity 1).This report is for one (1) 11mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 2 for (b)(4).

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.H3, h4, h6: part 04.037.145s, lot h823154: manufacturing location: monument.Manufacturing date: march 19, 2019.Expiration date: january 01, 2029.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.H3, h6: a product investigation was completed: the received nail shows several mechanical damages on the surface.There are deep marks inside the transversal hole.In general, the device is in a very used condition with discolorations and scratches all over.The lock prong feature of the internal locking mechanism is intact but was found stuck/ jammed.All features related to the reported complaint condition were reviewed and no other issues were identified.The function test was conducted with the also received tfna screw.The screw was able to pass through the tfna nail's transversal hole without any issue.The locking mechanism could be unlocked with a corresponding device.After unlocking, the mechanism is movable without any other issue detected.Furthermore, the tfna screw could be locked and unlocked as per design intended.Dimensional inspection showed the outer diameter head was within specification, but the transversal hole between nail head and nail shaft was damaged.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The complaint condition of blade migration could be confirmed based on the provided x-rays.However, a replication of the implanted condition could not be performed during the investigation.There was no manufacturing related issue.While no definitive root cause could be determined, it is possible a misalignment event has taken place during implementation surgery.Misalignment takes place when the connection between the involved parts are not parallel or not angular.This situation increases friction along the bearing surfaces and can turn into a damage and can compromise the functionality of the device.Moreover, it also not possible to determine when the locking mechanism got stuck/ jammed and if this situation could have contributed to the malfunction of the device.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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 235MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10680157
• MDR Text Key: 211449325
• Report Number: 8030965-2020-07925
• 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,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.145S
• Device Lot Number: H823154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 11/23/2020
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L36 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN
• Patient Outcome(s): Required Intervention