MAUDE Adverse Event Report: SYNTHES USA 3.2MM DRILL BIT/QC/145MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number 310.310

Device Problem Dull, Blunt (2407)

Patient Problem Sedation (2368)

Event Date 09/22/2015

Event Type  Injury  

Manufacturer Narrative

Additional product codes ¿ gff, gfa, hsz.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: during a hip osteosynthesis surgery, the dhs/dcs direct measuring device was not legible and the doctor was unable to use it.The dhs/dcs wrench did not couple with the screw correctly.The drill bit 3.2 mm, l 145/120mm and drill bit 3.2 mm, l 225/200mm did not have the correct edge and it was difficult to cut the bone.The doctor reportedly applied less than 10 - 20 pounds to cut the bone.There was a prolongation in surgery of 30-45 minutes.No additional patient harm reported.This is report 4 of 5 for (b)(4).

• Brand Name: 3.2MM DRILL BIT/QC/145MM
• Type of Device: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5127336
• MDR Text Key: 27453741
• Report Number: 2520274-2015-16433
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• 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