MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY RECIPROCATOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.615

Device Problems Overheating of Device (1437); Mechanical Jam (2983); Noise, Audible (3273)

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

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.The device was evaluated, and the reported condition was confirmed.A visual and functional assessment was performed which found that the unit failed the trigger test check (trigger was binding) and check the oscillations frequency, 10600 to 16000 oscillation/minute (vibrating excessively).It was further determined that the device became hot and had excessive noise inside.During service/repair, it was determined that there was an unknown liquid residue on the motor front shaft, the ball on the gear was completely broken, and the gear completely seized and would not reciprocate.The assignable root causes were determined to be due to normal wear out from use and improper cleaning.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that the battery reciprocator device was defective.During in-house engineering evaluation, it was observed that the unit failed the trigger test check (trigger was binding) and check the oscillations frequency, 10600 to 16000 oscillation/minute (vibrating excessively).It was further determined that the device became hot and had excessive noise inside.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY RECIPROCATOR
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8047408
• MDR Text Key: 126517275
• Report Number: 8030965-2018-57926
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819137134
• UDI-Public: (01)7611819137134(11)120510
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.615
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Date Manufacturer Received: 10/22/2018
• Date Device Manufactured: 05/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1