MAUDE Adverse Event Report: SYNTHES JENNERSVILLE DHS®/DCS® COUPLING SCREW; EXTRACTOR

Catalog Number 338.31

Device Problem Break (1069)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)

Event Date 09/12/2014

Event Type  Injury  

Event Description

It was reported that an open reduction internal fixation proximal femur revision surgery was performed on (b)(6) 2014 for nonunion as revealed by x-rays on an unknown date.Original surgery date as reported by sales consultant was (b)(6) 2013 or (b)(6) 2014.During the revision surgery an intact plate and all 4-5 broken cortex screws were removed.During the revision surgery the coupling screw was inserted through the one step insertion wrench and attached to the lag screw.While the surgeon was attempting to insert the lag screw the coupling screw fell off at the intersection of the two parts.When he pulled the coupling screw out he noticed the threads of the coupling screw had broken off into the patient.The fragments were retrieved with pliers and confirmed removed via x-rays.The surgeon was able to complete the surgery successfully using the same lag screw.No surgical delay reported.This is report number 1 of 4 for (b)(4).

Manufacturer Narrative

Event date: reported as (b)(6) 2013 or (b)(6) 2014.Implant and explant dates: device is an instrument and is not implanted/explanted.(b)(4).A device history review was conducted.The report indicates that there no issues were found during manufacture that would contribute to the complaint condition.Subject device has been received and is currently in the evaluation process.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.

Manufacturer Narrative

Additional narrative: a pd evaluation was conducted.The report indicates that the coupling screw is utilized in the lcp dynamic helical hip system ((b)(4)) and dhs/dcs dynamic hip and condylar screw system ((b)(4)) to aid in the insertion of a lag screw.One coupling screw (part 338.31, lot 7563286, mfg jan2014) was returned with the complaint that: ¿while removing the dynamic hip screw /dynamic condylar screw the connecting screw broke.During the revision surgery the coupling screw was inserted through the one step insertion wrench and attached to the lag screw.While the surgeon was attempting to insert the lag screw the coupling screw fell off at the intersection of the two parts.When he pulled the coupling screw out he noticed the threads of the coupling screw had broken off into the patient.The fragments were retrieved.¿ upon receipt of this device it was seen that the distal 7mm of threading is no longer attached and was not returned.This complaint is confirmed.The drawings for this part were reviewed ((b)(4)) and the design, materials and finishing process were determined to be adequate for the intended use of this device.Given the complaint description and the state of the returned device, it is likely that either excessive off-axis force was applied to the device or resistance while torquing was met during the lag screw insertion to cause this breakage.This complaint is confirmed; however, the root cause is most plausibly the application of off-axis force or over torquing during insertion.Event date: reported as (b)(6) 2013 or (b)(6) 2014.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® COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer (Section G): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4154800
• MDR Text Key: 4912068
• Report Number: 3003787298-2014-10048
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2014

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: 338.31
• Device Lot Number: 7563286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 10/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention