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

Catalog Number 280.900S

Device Problem Fitting Problem (2183)

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

Event Date 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

Patient id/initials and weight are unknown.Udi: (b)(4).Due to intra-operative issues, the device was not implanted/explanted.Phone number: (b)(6).Manufacturing location: (b)(4).Manufacturing date: august 30, 2016.Expiry date: august 01, 2026.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 that during surgery for a right femur fracture the dynamic compression screw (dhs) from the dynamic hip system (dhs) did not fit into the locking compression plate (lcp).They changed the screw and used another one with the same reference but different lot number to finish the intervention.There was no impact on the patient but a delay to change the screw.No information about patient condition received and how long the surgery was prolonged.There was no impact on the patient.Concomitant reported part: locking compression plate (part 02.224.208s, lot 9855652, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a product investigation was completed: the positioning groove of the dhs/dcs screw is expanded and damaged.The measurable dimensions of the dhs/dcs screw were as far as possible checked and found to be in compliance with the technical drawings and specifications.The device history record review shows that the correct material and manufacturing procedures were used.The examination of the raw-material testing certificate showed no deviations regarding material analysis, strength and structural stability.The values were in compliance with specifications and with the international standards for stainless steel.Our investigation has shown that the positioning groove of the screw is expanded and damaged.Unfortunately we only have limited information in the complaint description and cannot confirm how this happened.It is likely that the connection between the wrench and the screw was not aligned as intended and therefore this occurrence in combination with a mechanical overload situation could led to the complaint condition.No product fault could be found.Finally we conclude that the cause of failure is not due to any manufacturing non-conformances.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-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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6214162
• MDR Text Key: 63623319
• Report Number: 3009450863-2016-10028
• 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: 12/05/2016

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: 280.900S
• Device Lot Number: L110079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR