MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL RASPING MACHINE PLUS

Catalog Number 75002326

Device Problems Detachment Of Device Component (1104); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/28/2017

Event Type  malfunction  

Event Description

During surgery, the bottom came off from the rasping machine, resulting in a 2 hour delay to the procedure whilst a replacement device was located.

Manufacturer Narrative

Sign to withdraw 30-day medical device report.During the investigation, it has been detected that smith & nephew is not the legal manufacturer of this medical device.The initial medical device report has been filed in error to the fda.

Manufacturer Narrative

The complaint device sl-plus rasping machine is a third party product, it is returned and sent for investigation to the legal manufacturer (b)(4).The visual inspection by s+n confirms that the release button on the woodpecker adapter is disassembled.The evaluation by the legal manufacturer (b)(4) says in the analysis that the inspection shows a slow micro fracturing of the inner screw, leading over the time to the total metal fatique breakage of the adapter.Actions taken by the legal manufacturer is the repair of the adapter.The complaint device is returned to the customer.

• Brand Name: PLUS SL RASPING MACHINE PLUS
• Type of Device: RASP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001 ; SZ 5001
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001 ; SZ 5001
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6793656
• MDR Text Key: 82875515
• Report Number: 9613369-2017-00044
• Device Sequence Number: 1
• Product Code: HTR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75002326
• Device Lot Number: 07088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1