MAUDE Adverse Event Report: SYNTHES GMBH SPIRAL BLADE F/EXPERT RFN L70 TAN GOLD; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.013.046

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.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.A device history record (dhr) review was conducted: part number: 04.013.046, lot number: 11l1938, part manufacture date: jul 01, 2019, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of spiral blade f/expert rfn l70 tan gold product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history review: this lot met all dimensional, visual 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 (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) spiral blade f/expert rfn l70 tan gold.This is report 5 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: SPIRAL BLADE F/EXPERT RFN L70 TAN GOLD
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10876985
• MDR Text Key: 217437261
• Report Number: 8030965-2020-09119
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982087461
• UDI-Public: (01)10886982087461
• Combination Product (y/n): N
• PMA/PMN Number: K033618
• 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: 04.013.046
• Device Catalogue Number: 04.013.046
• Device Lot Number: 11L1938
• 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; LOCKSCR Ø5 L66 F/NAILS TAN LIGHT GREEN; 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; LOCKSCR Ø5 L66 F/NAILS TAN LIGHT GREEN
• Patient Outcome(s): Required Intervention