MAUDE Adverse Event Report: AESCULAP IMPLAINT SYSTEMS CASPAR RONGEURSTRSERR 3X12MM140MM; BONE PUNCHES, RONGEURS

Model Number FF503R

Device Problems Loose or Intermittent Connection (1371); Structural Problem (2506)

Patient Problem Failure of Implant (1924)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

The optically, the motor is in a good condition.The lever is not fixed at the motor as intended.One repaired/maintenance can be found within our system from january 2006.No further repairs/maintenances took place in (b)(4) since that date.Currently the product shows a "2019-12" labeling as the next maintenance date, hence we assume that the motor was maintained by an external ats.It can be confirmed that the pin has come loose from the lever.The performance data are according to the specification.The bore at the lever seems to be worn.Therefore the welded joint as well as the pin becomes loose.It is possible that the worn bore was generated during a rework/maintenance procedure at the external ats.The device history records have been checked for the above mentioned lot numbers and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot number (51242053).The failure is mostly probably repair/maintenance related.No capa is necessary.

Event Description

It was reported that the io piece broke off inside the disc.During surgery, the pituitary forceps broke.Piece of instrument broke off inside disc space.Could not be retrieved.In attempting to remove metal piece a small disc leak encountered.It confirmed metal fragment well binded in disc.3x does iv antibiotics.3x doses iv antibiotics.Oral antibiotics for 5 days.Report received from a solicitors on behalf of a client (see attached).The client was admitted to hospital under the care of a consultant orthopaedic surgeon, on the (b)(6) 2017 for l4/l5 discectomy.

• Brand Name: CASPAR RONGEURSTRSERR 3X12MM140MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP IMPLAINT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLAINT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: lindsay chromiak ; 3773 corporate pkwy; center valley, PA 18034
• MDR Report Key: 8572952
• MDR Text Key: 144970163
• Report Number: 9610612-2019-00237
• Device Sequence Number: 1
• Product Code: HTX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF503R
• Device Catalogue Number: FF503R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/03/2019
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1