MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM; APPLIANCE, FIXATION, NAIL

Catalog Number 280.900

Device Problem Fitting Problem (2183)

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

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown due to intra-operative issues, the device was not implanted/explanted.(b)(6).Manufacturing location: (b)(6).Manufacturing date: (b)(6) 2014.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 (b)(4) reports an event in (b)(6) as follows: it was reported that during surgery performed on (b)(6) 2016 the dynamic hip system (dhs) screw did not fit in the dhs plate.The surgeon used another dhs screw and the surgery was not prolonged.The surgery was successfully completed.No information about patient condition available.Concomitant reported parts: dynamic hip system plate (part/lot: unknown, quantity this is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed on the subject device dhs®/dcs® lag screw 12.7mm thread/90mm (part # 280.900, lot # 9167011).The investigation has shown that the positioning groove of the dhs/dcs® screw is expanded and damaged; there are some burrs and dents visible.The review of the production histories revealed that this dhs/dcs® screw was manufactured in october 2014.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.All described nonconformities are post manufacturing.The type and extent of damage incurred indicate that the positioning groove has been widened up due to inadequate handling.In order to ensure a correct load transfer it is crucial to have an appropriate connection between the dhs-screw and the connecting screw 338.310, which is guided through the appropriate dhs/dcs wrench.Dimensions: failed due to the damage incurred; dimensions were checked randomly at the time of manufacturing with no issues documented that would contribute to this complaint condition.No definitive root cause was able to be determined; the type and extent of damage incurred indicate that the positioning groove has been widened up due to inadequate handling.No product related issues were found.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: DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6148262
• MDR Text Key: 61544471
• Report Number: 3009450863-2016-10027
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791619
• 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
• Report Date: 11/08/2016

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: 280.900
• Device Lot Number: 9167011
• Other Device ID Number: (01)07611819012721(10)9167011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 UNKNOWN DYNAMIC HIP SYSTEM PLATE