MAUDE Adverse Event Report: SYNTHES (USA) TORQUE-LIMITING RATCHET HANDLE 7NM

Catalog Number 03.627.017

Device Problem Output Problem (3005)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer reported that device did not give enough torque.This is report 1 of 1 for complaint #(b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.The device was returned, the reported condition was not duplicated or confirmed.An assignable root cause is undetermined.Placeholder.

• Brand Name: TORQUE-LIMITING RATCHET HANDLE 7NM
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4128325
• MDR Text Key: 15805549
• Report Number: 8030965-2014-01508
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.627.017
• Device Lot Number: 87818-047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1