MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEUR UP-BITE 2MM 155MM; BONE PUNCH

Model Number FF842R

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Country of complaint: (b)(6).Patient underwent an l3/4 lateral decompression laminotomy/microdiscectomy rhizolysis.During the procedure the surgeon was utilizing a pituitary rongeur for lateral discectomy when it broke.A.5mm x 10mm fragment broke off and lodged within the posterolateral disc space, which was confirmed by x-ray.After seeking a second surgical opinion and discussion with his own surgeon the patient decided to discharge home from hospital with the fragment insitu.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the instrument.Here we found a broken off jaw part.Additionally we found withdrawn pins.Furthermore we found a visibly damaged cutting edge.Additionally we found withdrawn pins.Furthermore, we found a visibly damaged cutting edge.Additionally we found gaps between the ending of the upper jaw part ff842210 and the slot of the lower jaw part ff842211.Furthermore we found a bent end of the upper jaw part.We made a visual inspection of the fracture surface.Here we found a crack.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: according to the quality standard, a material defect and production error can be excluded.No pores or foreign bodies could be found on the point of rupture.We assume a mechanical overload situation as a causal factor.The withdrawn pins, gaps and bent end of the upper jaw part are indications of a mechanical overload situation.The crack were caused due to the breakage.No capa is necessary.

• Brand Name: CASPAR RONGEUR UP-BITE 2MM 155MM
• Type of Device: BONE PUNCH
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5743473
• MDR Text Key: 47997389
• Report Number: 2916714-2016-00497
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FF842R
• Device Catalogue Number: FF842R
• Device Lot Number: 4503653830
• Distributor Facility Aware Date: 06/09/2016
• Date Manufacturer Received: 05/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other