MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS TRIAL INSERT H 32MM SYM.; INSTRUMENT FOR HIP ENDOPROTHESIS SURGERY

Model Number NT504

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

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

Event Type  malfunction  

Event Description

Intra-operative feathering burr in long hole when applying with forceps and fragments were breaking off.Fragments may remain in patient.No harm to patient, no delay to procedure reported.

Manufacturer Narrative

Manufacturing site evaluation: samples received: 8 trail inserts were provided for investigation.Analysis and results: the trial inserts show several damages around the long holes, which appear to have occurred due to incorrect placement of the forceps.The forceps may have slipped out of the long holes leaving the damage.There are no other complaints on file for this product/issue, therefore a systematical error in manufacturing and in materials has been excluded.Final conclusion: complaint is not justified.The failure is user related.Corrective/preventive actions: there are no safety problem and all the regulatory requirements have been met.

• Brand Name: TRIAL INSERT H 32MM SYM.
• Type of Device: INSTRUMENT FOR HIP ENDOPROTHESIS SURGERY
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5112460
• MDR Text Key: 27146190
• Report Number: 3005673311-2015-00139
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NT504
• Device Catalogue Number: NT504
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other