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

Catalog Number 338.31

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Patient involvement in the reported case is unknown.Date of device breakage is unknown.Device is an instrument and is not implanted or explanted.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacture date: august 12, 2002.The review of the device history records showed that there were no issues or non-conformances during the manufacture of the product that would contribute to this complaint condition.Device 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 (b)(4) reports an event as follows: it was reported that the tip of dynamic hip screw/dynamic condylar screw (dhs/dcs) coupling screw broke.Additional information pertaining to patient and/or surgical involvement is unknown.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Additional narrative: clarified the manufacturer¿s complaint number.Product investigation summary: the returned instrument was examined and the complaint condition was able to be confirmed as the returned coupling screw was missing the threaded tip.As specifics regarding the technique at the time of failure were not provided, no definitive root cause was able to be determined; excessive loading and/or off-axis force application likely contributed to the complaint condition.The dhs/dcs coupling screw is a component of the dhs one-step basic set, which can be utilized during dynamic hip and condylar screw (dhs/dcs) procedures utilizing the one-step technique.The coupling screw is inserted into the wrench and, after sliding the dhs plate onto the shaft of the wrench, the appropriate lag screw can be seated on the end of the wrench and secured using the coupling screw.The returned instrument was examined and the complaint condition was able to be confirmed as the returned coupling screw was missing the threaded tip (approximately 8mm x 2.6mm).The relevant drawings for the returned instruments were reviewed.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instrument¿s lot numbers and in each instance there were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Device 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

This report is for (b)(4).

• Brand Name: DHS®/DCS® COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5295070
• MDR Text Key: 34015689
• Report Number: 2530088-2015-10727
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

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: 4457514
• Other Device ID Number: (01)10886982193322(10)4457514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2002
• 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