MAUDE Adverse Event Report: SYNTHES GMBH EXPERT END CAP F/HAN TAN GOLD; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.008.000S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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.Device history lot.Sterile part: part: 04.008.000s, lot: 6l33688, manufacturing site: (b)(4), supplier: früh verpackungstechnik ag, release to warehouse date: oct.18, 2019, expiry date: oct.01, 2029.Since there is no allegation against packing or sterility, a manufacturing record evaluation was not performed.Non-sterile part: part # 04.008.000, synthes lot # 10l1314, supplier lot # 10l1314, supplier: jabil inc.-(b)(4), release to warehouse date: sep 19, 2019.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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 or Problem 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) expert end cap f/han tan gold.This is report 1 of 6 for (b)(4).
Additional 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: EXPERT END CAP F/HAN TAN GOLD
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10877042
• Report Number: 8030965-2020-09112
• Device Sequence Number: 14177004
• Product Code: HSB
• UDI-Device Identifier: 10886982087133
• UDI-Public: (01)10886982087133
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K051678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.008.000S
• Device Catalogue Number: 04.008.000S
• Device Lot Number: 6L33688
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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; SPIRAL BLADE F/EXPERT RFN L70 TAN GOLD
• Outcome Attributed to Adverse Event: Required Intervention