MAUDE Adverse Event Report: AESCULAP AG BECK STR RONGEURS 2X140MM; BONE PUNCHES, RONGEURS

Model Number FF765R

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).It was reported that the rongeur broke inside a patient during surgery.The piece was retrieved from the patient.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with the keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the instrument.Here we found visible damage on part kr-765-002-03 and typical signs of crevice corrosion.Additionally we made a visual inspection of the fracture surface of the broken off jaw kr-765-002-03.Here we found the typical signs of stress corrosion.Hardness was checked in the area of the broken part and according to specification it is not in the allowable tolerance with 557 hv5 (53 hrc).Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: the increased hardness has a higher strength as a consequences.Furthermore the ductlilty decreased but we do not regard this as the decisive reason.We assume that a mechanical overload has caused cracks.By reprocessing of the instrument caused a stress and crevice corrosion.Without further knowledge about the circumstances we assume a mechanical overload situation as the causal factor.The breakage was probably contributed by stress corrosion.No capa is necessary.

• Brand Name: BECK STR RONGEURS 2X140MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6647280
• MDR Text Key: 77772274
• Report Number: 9610612-2017-00328
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/02/2017

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 Model Number: FF765R
• Device Catalogue Number: FF765R
• Device Lot Number: 4501945624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/07/2017
• Device Age: 8 YR
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 05/31/2017
• Supplement Dates FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other