MAUDE Adverse Event Report: SYNTHES MONUMENT STARDRIVE SCREWDRIVER SHAFT T8 105MM; SCREWDRIVERS

Catalog Number 314.467

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sedation (2368)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

Patient age is unknown; patient is described as an octogenarian device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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: variable angle-distal humerus plate (va-dhp) of medial and dorsolateral were used for an octogenarian female.Plate bending was applied to fix plate in the right position.The surgeon had difficulty to attach the drill sleeve, and found some string-shaped metal debris had come from the reported va-locking screw on the inserting.Therefore, he removed the reported screw.The surgeon inserted another screw instead.The surgeon tightened the screw to some extent because no click sound could be heard.The surgery was extended for thirty (30) minutes.No harm to the patient.This is report 6 of 6 for (b)(4).

Manufacturer Narrative

(b)(4): subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: universal punch manufactured the stardrive screwdriver shaft t8, 105mm, p/n 314.467, lot number 7867509.There were no mrrs, ncrs, or complaint-related issues with this lot.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

A product investigation was completed: 314.467: on both devices the first 6-7 mm shows wear and tear signs.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Based on the provided clinical information it is impossible to determine the exact cause of this occurrence.It is likely that the screw was not been positioned accordingly so that the thread at the screw shaft got damaged during the insertion.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy.Due to the wear and tear signs we conclude that the cause of failure is not due to any manufacturing non-conformances.No product fault could be detected.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: STARDRIVE SCREWDRIVER SHAFT T8 105MM
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5050736
• MDR Text Key: 24879193
• Report Number: 1719045-2015-10572
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314.467
• Device Lot Number: 7867509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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