MAUDE Adverse Event Report: SYNTHES SELZACH DOUBLEAIRHOSE F/MINI AIR DRILL NO. 512.1; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT

Catalog Number 512.150

Device Problem Air Leak (1008)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).The 510k is not available as the device is currently in preamendment.The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device had a leaky hand piece and a leaking hose at the engine clutch.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by (b)(6) that during service and evaluation, it was observed that the double air hose device had a leaky hand piece and a leaking hose at the engine clutch.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: DOUBLEAIRHOSE F/MINI AIR DRILL NO. 512.1
• Type of Device: INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5232499
• MDR Text Key: 31748632
• Report Number: 3000270450-2015-10232
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2015

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: 512.150
• Device Lot Number: 13820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1