MAUDE Adverse Event Report: SYNTHES SELZACH DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/85MM-STERILE; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 280.285S

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

Patient weight not available for reporting.Date of device migration is not known.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Please note, this dhr review is for sterilization procedure only 280.285s - l039304 no ncrs 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.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: 27.Jun.2016.Expiry date: 01.Jun.2026.Non-sterile.280.285 - h098226.Dhr review for part # 280.285, supplier lot # h098226.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Release to warehouse date: 06-jun-2016.Manufactured by: (b)(4).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 patient was implanted with a locking compression plate (lcp) dynamic hip system (dhs) plate and screws on (b)(6) 2017.Patient suffered a fall on unknown date post-operative.X-ray shows the femoral head/neck had collapsed and the screws had cut out, rendering the fracture unstable.Patient was returned to surgery on (b)(6) 2017 and revised to trochanteric fixation nail advanced (tfna) implants.Patient was again returned to surgery on (b)(6) 2017 for revision of the tfna implants.Tfna revision is addressed in (b)(4).Concomitant device reported: 130 degree lcp dhs plate (02.224.204s, lot l039943, quantity 1).This report is for one (1) lag screw.This is report 1 of 2 for (b)(4).1x plate 02.224.204s lot.L039943.

Manufacturer Narrative

A product development evaluation was completed: the product was not returned for investigation.The case and x-ray were sent to the product development team for a design review.The patient had a post-operative fall, which resulted in failure of the lcp dhs implant.The implant was removed and replaced with a tfna.No design related root cause has been identified.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® ONE-STEP LAG SCREW 12.7MM THREAD/85MM-STERILE
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6575573
• MDR Text Key: 75451627
• Report Number: 3000270450-2017-10170
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.285S
• Device Lot Number: L039304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention