MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS DOUBLE AIR HOSE SCHRADER STEM 2 METERS; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT

Catalog Number 512.15S

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 09/30/2014

Event Type  malfunction  

Event Description

It was reported that during testing prior to surgery, it was discovered that the double air hose device broke.According to the report, the device made a very loud popping noise after a few seconds of use and the end broke off inside.The reporter stated that this was a brand new device and the first time it was used.It was not reported if there were any delays to the surgical procedure.An identical spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned and is currently pending evaluation.Once (b)(4) evaluates the device, a follow-up medwatch will be submitted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device returned date: the device returned date was documented as oct 8, 2014 in the initial report.The device was not returned for evaluation.Therefore, the reported complaint could not be confirmed.No further investigation is required at this time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: DOUBLE AIR HOSE SCHRADER STEM 2 METERS
• Type of Device: INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; ni
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; ni; ni
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4175617
• MDR Text Key: 16539730
• Report Number: 2520274-2014-14041
• Device Sequence Number: 1
• Product Code: HSZ
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2014

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: 512.15S
• Device Lot Number: H263095873
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1