MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ACCULAN 3TI DRILL ATTACHM.LARGE JACOBS; POWER SYSTEMS ORTHOPAEDICS

Model Number GB638R

Device Problem Defective Device (2588)

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

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

Aesculap inc.(importer) is submitting this report on behalf of aesculap ag (manufacturer).Exemption number: e2014018.Manufacturing site evaluation: evaluation on-going; results will be provided, if available.

Event Description

It was reported that there were issues with the acculan drill attachment.Cuttings were located during the internal hospital validation; the cuttings could not be removed during cleaning.Residues were found in the liquid (eluate).The facility noted that many wound healing disorders were identified after hip replacements (tep); the staff was concerned about the "cuttings".

• Brand Name: ACCULAN 3TI DRILL ATTACHM.LARGE JACOBS
• Type of Device: POWER SYSTEMS ORTHOPAEDICS
• 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
• MDR Report Key: 7213604
• MDR Text Key: 198712133
• Report Number: 9610612-2017-00631
• Device Sequence Number: 1
• Product Code: HWE
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB638R
• Device Catalogue Number: GB638R
• Device Lot Number: 52040247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other