MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM-STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 280.950S

Device Problem Fitting Problem (2183)

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

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Udi: (b)(4).Initial reporter: reporting facility phone number is (b)(6).Reporter¿s last name was not provided.This device was not implanted in the patient.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2016, the dynamic hip system screw (dhs) did not fit in the hole of the locking compression dhs plate.A different plate and screw were used to complete the procedure.The surgery was successfully completed with no reported delay and no harm to the patient.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Report was initially submitted on jun 24, 2016 but the report did not pass the first acknowledgement in the fda portal.Advised by fda on jun 30, 2016 to resubmit medwatch.Device was not implanted/explanted.A product investigation was completed: received parts: screw (part 280.950s, lot number 8590276) and plate (part 02.224.205s, lot number 8002687).The positioning groove of the dhs/dcs screw is expanded and damaged.The plate shows scratches all over on the surface.No significant damage visible.The dimensions of the dhs/dcs screw, which are relevant for the complaint condition as far as possible checked and found to be in compliance with the technical drawings.The outside diameter is within tolerance.Due to the damages no further dimension could be measured.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 specifications and international standards.There was limited information in the complaint description and therefore how the complaint condition happened cannot be confirmed.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.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

Concomitant reported parts: locking compression plate (part 02.224.205s, lot 8002687, quantity 1).

• Brand Name: DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM-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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5653662
• MDR Text Key: 45151502
• Report Number: 3009450863-2016-10013
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2016

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 Expiration Date: 08/01/2023
• Device Catalogue Number: 280.950S
• Device Lot Number: 8590276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1