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

Catalog Number 280.000

Device Problem Fitting Problem (2183)

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

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Due to the intra-operative event, the device was not implanted or explanted.Hospital contact number: (b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: september 4, 2006.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a dynamic hip screw (dhs) lag screw was tested prior to insertion during a surgical procedure on (b)(6) 2016.The surgeon was not able to pass the lag screw through the plate.As a result, another lag screw was used to complete the procedure.No delay or additional medical intervention was noted.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: only the dhrs/dcs screw (part 280.000 / lot 2215445) was received for investigation.The microscopic examination shows post-manufacturing damage.The positioning groove of the dhs/dcs screw was expanded and damaged.The outside diameter at the area of the positioning groove is enlarged and is likely the reason that the dhs/dcs screw could not pass the bore of the lcp dhs plate anymore.The side walls of the positioning groove show dents and marks; the dimensions cannot be verified against post-manufacturing specifications.The device history record review revealed that the dhs/dcs screw was manufactured according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.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 points out that the user should avoid damaging the instruments and the implant by tightening the connecting screw securely.The manner of the damages indicates misuse and mechanical overloading due to an error in following the surgical technique instructions.No manufacturing related issues were identified and/or confirmed.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
• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5551914
• MDR Text Key: 42002125
• Report Number: 9612488-2016-10176
• 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: 03/17/2016

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: 280.000
• Device Lot Number: 2215445
• Other Device ID Number: (01)07611819012547(10)2215445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1