MAUDE Adverse Event Report: SYNTHES BETTLACH 3.5MM TI LOCKING SCREW SELF-TAPPING 28MM; APPLIANCE, FIXATION, NAIL

Catalog Number 413.028

Device Problem Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that while inserting the 3.5 locking screws to philos, the paint of the screw was stripped and left a coil.The surgeon did irrigation for an additional thirty minutes.No patient harm was reported.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device was not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product 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.

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: the microscopic investigations of the complained locking screw manufactured in october 2012 shows that the thread on the screw shaft was damaged during use.The tip of the flanks was partially sheared off resulting in the visible burr.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.The anodized green color was abraded almost on the entire length.The flanks are rounded and worn.The review of the manufacturing documents showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The condition of the returned device indicates that the screw came in contact with the plate during insertion or extraction while use.No product related condition was 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: 3.5MM TI LOCKING SCREW SELF-TAPPING 28MM
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3881020
• MDR Text Key: 4542641
• Report Number: 9612488-2014-10232
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 413.028
• Device Lot Number: 8123116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1