MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR 5 L66 F/NAILS TAN LIGHT GREEN; SCREW,FIXATION,BONE

Model Number 04.005.556

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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) 2020, the patient underwent revision surgery around 9pm to reposition the expert han nail, expert end cap, spiral blade, and three (3) locking screws.The original procedure was completed on (b)(6) 2020 in the afternoon.The surgeon originally placed the expert han nail but diagnostic imaging showed evidence that the expert han nail remained extramedullary in the mid-distal third of the tibia.This required revision surgery to carry out repositioning of the implants.There was patient consequence.This complaint involves six (6) devices.This report is for (1) lockscr ø5 l66 f/nails tan light green.This is report 4 of 6 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.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: LOCKSCR 5 L66 F/NAILS TAN LIGHT GREEN
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10876975
• MDR Text Key: 217436320
• Report Number: 8030965-2020-09118
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982086242
• UDI-Public: (01)10886982086242
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.005.556
• Device Catalogue Number: 04.005.556
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Patient Sequence Number: 1
• Treatment: EXPERT END CAP F/HAN TAN GOLD; EXPERT HAN Ø10 LE CANN L240 TAN LIGHT GR; LOCKSCR Ø5 L30 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L30 F/NAILS TAN LIGHT GREEN; SPIRAL BLADE F/EXPERT RFN L70 TAN GOLD; EXPERT END CAP F/HAN TAN GOLD; EXPERT HAN Ø10 LE CANN L240 TAN LIGHT GR; LOCKSCR Ø5 L30 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L30 F/NAILS TAN LIGHT GREEN; SPIRAL BLADE F/EXPERT RFN L70 TAN GOLD
• Patient Outcome(s): Required Intervention