MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS UNKNOWN

Catalog Number UNK_PRODUCT

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).The product code is unknown.Therefore, the brand name, common device name, catalog number and 510k classification are unknown.The manufacturing location was unknown.The lot/serial number device is unknown; therefore, the manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 from (b)(6) that after surgery, it was observed that an unknown saw blade device broke off and became stuck in the connection point of the air reciprocator device.There was no patient involvement.It was not reported if there were any 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.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the rear part of the saw blade device was stuck inside the coupling and had to be removed by disassembling the quick coupling.It was noted that the front part of the saw blade device was not available.It was further determined that the rear part of the saw blade device in the saw blade quick coupling was firmly clamped.During investigation, the part of the saw blade device was inspected and it was determined that the saw blade device did not match the synthes specification (dimensions and coating), indicating that the device was not produced by synthes.The rear part of the saw blade device stuck inside the coupling was confirmed.The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5310582
• MDR Text Key: 34612658
• Report Number: 2520274-2015-17954
• Device Sequence Number: 1
• Product Code: HSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• 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,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PRODUCT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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