MAUDE Adverse Event Report: SYNTHES BETTLACH SPIKED WASHER 13.5MM/4.0MM; BOLT, NUT, WASHER

Catalog Number VP1301.02

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  malfunction  

Manufacturer Narrative

Device used in a veterinary case - no patient information will be reported.Date of event: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6) device is a veterinary product, but is similar to device used on humans.Manufacturing location: bettlach.Supplier: (b)(4).Manufacturing date: february 12, 2015.No anomalies were detected during device history record review.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that an anterior cruciate ligament (acl) broke.On (b)(6) 2015: extracapsular stabilization by ligament graft (1/3 lateral patellar tendon + fascia lata) secured by washer screws on the lateral femoral condyle.On (b)(6) 2015: wound flowing.On (b)(6) 2015: x-ray: peek washer out of the screw, seroma.Excision and sending the washer to laboratory for bacteriological examination.On (b)(6) 2015: takeover by plateau leveling osteotomy (tplo).On (b)(6) 2016: tplo infection.To this day: total bone healing and infection.This report is for a veterinary case; there was no human patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4) infection, reported incorrectly.The infection events are being captured under linked complaints (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

The wound flowing on (b)(6) 2015 may have been due to escherichia coli.The washer and screw were explanted on (b)(6) 2015.On (b)(6) 2015, there was an implantation of a new plate and screws (tplo) because the initial screw wasn't holding on the ligament; it is unknown if these were synthes devices.This report is related to linked complaints (b)(4) which capture the infections.

Manufacturer Narrative

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

In regards to the screw not holding the ligament, it was noted by the manufacturer that the washer is indeed what is holding the ligament/tendon/graft, not the screw.The washer must be secured in proper location with the screw, but since the metal screw would not deform or move, the washer gave way.Therefore, no failure on the part of the screw.Concomitant reported part: 1 screw (part and lot number unknown).

• Brand Name: SPIKED WASHER 13.5MM/4.0MM
• Type of Device: BOLT, NUT, WASHER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5694387
• MDR Text Key: 47607671
• Report Number: 9612488-2016-10257
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VP1301.02
• Device Lot Number: 9339381
• Other Device ID Number: (01)07611819817807(10)9339381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1