MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/125MM-STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 280.250S

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the dhs screw 12,5mm do not fit in to the barrel in a lcp dhs plate.No patient injury.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient data available.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.Device history records was conducted.The report indicates that: this complaint is assessed as not related to sterilization.Thus, the documents for the corresponding non sterile part 280.250 lot 7932764 were reviewed with the following result: no ncrs 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.Manufacturing date: 17.Jun.2014 (delivered from (b)(4)).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a manufacturing investigation was performed for the returned dhs/dcs screw, part number 280.250s, lot 9018045 (subject device).The investigation of the dhs/dcs screw has shown that the positioning groove of the screw has been widened due to an inadequate handling.It is believed that the surgeon did not use the dhs/dcs-centersleeve, part number 338.320, which caused the deformation of the grooves (clearly visible).The grooves are expanded and damaged the plate does not pass the slotted end of the dhs/dcs screws anymore.The dhs/dcs screw was analyzed for conformance to print specifications as well as the device history record was researched, no abnormal findings were identified.Further investigation has shown that this instrument was manufactured in june 2014 according to the specification.The review of the production history revealed that subject device was manufactured according to the specifications.Neither a manufacturing nor a design related failure that would have contributed to this complaint condition was found.In conclusion, no product fault could be detected.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DHS®/DCS® LAG SCREW 12.7MM THREAD/125MM-STERILE
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4519174
• MDR Text Key: 5489376
• Report Number: 3009450863-2015-10003
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: 280.250S
• Device Lot Number: 9018045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 02/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1