MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/100MM -STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 280.000S

Device Problem Fitting Problem (2183)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Date of event: unknown.(b)(4).Device was not implanted/explanted.Manufacturing location: (b)(4).Manufacturing date: march 20, 2015, expiry date: march 01, 2025.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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 during surgery, the screw did not fit in the plate.There reportedly was no delay to surgery time.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing investigation evaluation: the positioning groove on the returned instrument is damaged due to inadequate handling.It is likely that the connection between the wrench and the screw were not aligned as intended.Therefore, this occurrence, in combination with a mechanical overload situation, could potentially lead to the deformation of the screw.Please note: in order to prevent such occurrences, and to ensure a correct load transfer, it is crucial to have an appropriate connection between the dhs-screw and the connecting screw.The surgical technique guide instructs the user to avoid damaging the instruments and the implant.Also, the connecting screw should be tightly secured.The device history record was researched with no abnormal findings identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Further investigation has shown that the implant was manufactured in march, 2015 according to the specification.Device 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: DHS®/DCS® LAG SCREW 12.7MM THREAD/100MM -STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5495870
• MDR Text Key: 40182460
• Report Number: 3009450863-2016-10006
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

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 Catalogue Number: 280.000S
• Device Lot Number: 9409531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1