MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS POWER MODULE FOR TRAUMA RECON SYSTEM; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.202

Device Problem Power Problem (3010)

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

Event Date 07/16/2014

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: optical check was ok; device shows signs of usage.The battery handpiece was dismantled and it was determined the magnetic support inside hand piece was broken.No issues during the assembly visible in the device history record.The probably root cause is material faulty could lead to the device failure.Since the sale of the product the service was not conducted.The product is outside the guarantee.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the trauma recon system (trs) stopped working during use, the battery module was replaced, but the hand piece did not work.There was no anomaly found with the battery modules.The operation was completed with a backup hand piece with a reported 5 minute delay.There was no reported harm to the patient.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

Additional narrative: a product development evaluation was completed: the examination of the different components shows that the magnet retainer assembled into the hand-piece is broken.This fact caused the event described into the complaint description.The breakage of the magnet retainer could have been caused by any of the following actions or by the combination of some of them: dropping of the hand-piece, (per the trauma recon system (trs) instruction for use, if a device drops, it has to be sent in for service); spring back / quick release of the trigger and poor design, or embrittlement of the peek due to the high sterilization temperature in combination with a drop or quick release.Tsr recon saw and trs modular have been tested during the development process, and, no adverse incident related to the magnet retainer was detected.It is not possible to precisely figure out the root cause of this complaint with the available information.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.No nonconformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: POWER MODULE FOR TRAUMA RECON SYSTEM
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3999897
• MDR Text Key: 11921658
• Report Number: 3009450871-2014-10321
• Device Sequence Number: 1
• Product Code: MOQ
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2012
• 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