MAUDE Adverse Event Report: SYNTHES HAGENDORF SMALL HEXAGONAL SCREWDRIVER LONG; GAUGE,DEPTH

Catalog Number 314.57

Device Problem Break (1069)

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

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient date of birth is not available for reporting.Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was completed for part # 314.57, lot # 5196445.Supplier lot # 1450801, manufacturing location: (b)(4), manufacturing date: feb 22, 2006.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It is reported that on (b)(6) 2016, patient underwent procedure for an open reduction and internal fixation of the acetabulum.During the procedure, surgeon was using the screwdriver as leverage against the plate when the shaft of the screwdriver broke into two pieces.Both pieces were easily retrieved.Another screwdriver was readily available and was used to complete the procedure successfully with approximately 1 minute delay.Concomitant devices reported: plate (part# unknown, lot# unknown, quantity 1) this report is for one (1) small hexagonal screwdriver long.This is report 1 of 1 for (b)(4).

• Brand Name: SMALL HEXAGONAL SCREWDRIVER LONG
• Type of Device: GAUGE,DEPTH
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6117554
• MDR Text Key: 60623988
• Report Number: 3003875359-2016-10609
• Device Sequence Number: 1
• Product Code: HTJ
• 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: Other
• Type of Report: Initial
• Report Date: 10/31/2016

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: 314.57
• Device Lot Number: 5196445
• Other Device ID Number: (01)10886982188984(10)5196445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2006
• 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
• Treatment: ONE (1) UNKNOWN PLATE
• Patient Age: 35 YR
• Patient Weight: 90