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

Catalog Number 338.310

Device Problem Break (1069)

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

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient age & weight not provided by reporter.(b)(6).The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa: device history records was conducted.The report indicates that the: 338.310 - (b)(4).Manufacturing site: (b)(4), manufacturing date: 29.Oct.2014, expiry date: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a trauma/procedure had taken place.As surgeon was inserting the dhs screw, he realized that the connecting screw is loose, so he tightened it.He mentioned that the whole step was repeated twice.After the last turn, he realized that the connecting screw tip was broken and was struck inside the dhs lag screw.The surgeon managed to remove the dhs lag screw with the dhs wrench.He requested second set to be open and another l90mm dhs lag screw was inserted.Unfortunately, the nurse has discarded the lag screw into the sharp box and only the instrument would be sent back for investigation.Patient outcome post-surgical procedure: optimal.10 minutes delay in surgery.No reported adverse event to patient.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

(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.

• Brand Name: DHS®/DCS® COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5237941
• MDR Text Key: 31673108
• Report Number: 3003875359-2015-10485
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

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: 338.310
• Device Lot Number: 9204288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• 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 Age: 61 YR