MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS LINDEMANN REAMER M Ø 2.3MM HEAD LENGTH 20.2MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 03.000.113S

Device Problems Break (1069); Material Discolored (1170)

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

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The manufacturing location was unknown.The device manufacture date is currently unavailable.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

This is report 1 of 2 of the same event.It was reported from (b)(6) that during an unspecified pediatrics surgical procedure, it was discovered that the reamer device broke and a second reamer device was discolored at the tip.During subsequent follow-up with the customer, it was confirmed that one of the reamer devices was discolored.It was further reported that the discoloration could be due to hear or corrosion; however, the reporter could not confirm it the discoloration was from overheating.There was a thirty minute delay to the planned surgical procedure.A spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The procedure was completed successfully.There was no undesirable outcome.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device broke off at the connection between reaming part and the shaft.That indicates that the reamer may have been subjected to high physical force during reaming.The breaking of the tip is most likely due to improper use, like the reamer has been used for drilling, with too high speed or with too much sideward pressure.The reamers are not suitable for drilling as the tip is not sharpened.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper use (use error).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LINDEMANN REAMER M Ø 2.3MM HEAD LENGTH 20.2MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5837105
• MDR Text Key: 52196093
• Report Number: 8030965-2016-14378
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.000.113S
• Device Lot Number: 9324826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• 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
• Patient Age: 15 YR