MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC DHS®/DCS® COUPLING SCREW; EXTRACTOR

Catalog Number 338.31

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).Patient weight not available for reporting.Device is an instrument and is not implanted/explanted.Returned to manufacturer.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

It was reported that during a revision surgery on (b)(6) 2017, the threads of a dynamic hip screw/dynamic condylar screw (dhs/dcs) coupling screw broke off in a 14mm thread dhs/dcs lag screw 95 mm.Patient was revised due to arthritis in the hip joint.Surgeon was removing a dhs side plate, lag screw and four (4) or five (5) cortical screws when the coupling screw threads broke off into the lag screw.Patient was revised to a total hip.Procedure was completed successfully.Revision procedure is addressed in (b)(4).This report addresses the intraoperative issue with the coupling screw.Concomitant device reported: lag screw (280.495, lot 477228, quantity 1).(b)(4).

Manufacturer Narrative

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

It was reported that during a revision surgery on (b)(6), 2017, the threads of a dynamic hip screw/dynamic condylar screw (dhs/dcs) coupling screw broke off in a 14mm thread dhs/dcs lag screw 95 mm.Patient was revised due to arthritis in the hip joint.Surgeon was removing a dhs side plate, lag screw and four (4) or five (5) cortical screws when the coupling screw threads broke off into the lag screw.Patient was revised to a total hip.Procedure was completed successfully.Revision procedure is addressed in (b)(4).This report addresses the intraoperative issue with the coupling screw.Concomitant device reported: lag screw (280.495, lot 477228, quantity 1).

Manufacturer Narrative

Customer quality conducted an investigation of the returned device.Investigation summary : the dhs/dcs coupling screw (338.31) is an instrument routinely used during dynamic hip and condylar screw (dhs/dcs) procedures when the one-step technique approach is desired.The instrument was visually inspected and the complaint condition was confirmed as the instrument was returned with a broken off threaded distal tip (lodged inside a dhs®/dcs® lag screw 14.0mm thread/95mm-sterile; part number: 280.495, lot number: 4772228)).Approximately 7.01 mm of the 8mm threaded length tip is broken off.Although a definitive root cause could not be determined, it is likely that this complaint condition was due to excessive mechanical loading and/or off-axis force application, possibly bending the shaft/tip of the instrument to the degree of snapping off.Replication of the complaint condition is non applicable due to post manufacturing damage.Relevant drawings for the returned instrument were reviewed (both current and from the time of manufacture): top-level.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and in each instance no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Dhr review was completed.Part # 338.31, synthes lot # 4033954, supplier lot # 4033954, expiration date: n/a, release to warehouse date: 29 nov 1999, manufactured by synthes (b)(4).No ncr¿s were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7146376
• MDR Text Key: 96127510
• Report Number: 2939274-2017-50434
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982193322
• UDI-Public: (01)10886982193322(10)4033954
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2017

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: 338.31
• Device Lot Number: 4033954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 12/26/2017; 01/23/2018
• Supplement Dates FDA Received: 12/27/2017; 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/1999
• 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 Age: 67 YR