MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem Sedation (2368)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.This report is for one (1) unknown nail.Without a valid part and lot number, a udi is not available.Device was not explanted.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Unknown, as specific part and lot numbers for the complainant nail are unknown.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested 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 in (b)(6) as follows: it was reported that a 4mm titanium elastic nail (ten) became stuck in the cutter instrument during a surgical procedure on (b)(6) 2015.The section to be cut was reportedly very short.As a result of the issue, the procedure was prolonged by thirty (30) minutes, but ultimately completed with a like product.This report is for one (1) unknown nail.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

During the investigation of cutting bolt, the unknown nail was found jammed into the device.Device investigation summary ¿ the device in question shows numerous marks at the arrester nut ((b)(4)).Furthermore we found that a unknown nail is jammed into the cutting bolt ((b)(4)).The nail is broken at the end of the cutting bolt.The broken part is available.Investigation results: the product was produced in (b)(4) 2015, there are several traces of mechanical damages found on the device.The device was able to be disassembled successfully - there was an unknown nail jammed into the cutting bolt.The nail was broken at the end of the cutting bolt and the broken surface shows marks of forced rupture.It is likely that no quality problems or failures were caused by a faulty product on the article.Based on the investigation results it is assumed that the cause of the breakage is the result of a mechanical overload situation during use.Because of the damage, the complaint relevant dimensions cannot be checked.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.The cause of failure is not due to any manufacturing non-conformances.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.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5270975
• MDR Text Key: 32796417
• Report Number: 2520274-2015-17703
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention