MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS PROBE FOR CPMS; MONITOR, PRESSURE, INTRACOMPARTMENT

Catalog Number 530.412

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2014

Event Type  malfunction  

Event Description

It was reported that during engineering evaluation, it was observed that the probe device had temperature above specification.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The manufacturing location was unknown.The device manufacture date is unknown.The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the temperature was above specification.The reported condition was confirmed.The assignable root cause was determined to be due to normal wear and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Correction: upon further investigation, it was determined that mfr# 2520274-2014-13088 is a duplicate of mfr# 2520274-2014-10911.Reference 2520274-2014-10911 for all further reporting regarding this event.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: PROBE FOR CPMS
• Type of Device: MONITOR, PRESSURE, INTRACOMPARTMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; ni; ni; ni
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4039082
• MDR Text Key: 4903170
• Report Number: 2520274-2014-13088
• Device Sequence Number: 1
• Product Code: LXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 08/06/2014

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: 530.412
• Device Lot Number: 25-1585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 08/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1