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 Wound Dehiscence (1154)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).Cuttings were located during the internal hospital validation.Residues found in the liquid (eluate).Wound healing disorders after many hip tep's were identified.They can not explain why the wound healing disorders are increasing and they think it could be due to the found 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 63042
• MDR Report Key: 7161811
• MDR Text Key: 96400080
• Report Number: 9610612-2018-00001
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2018

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: 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
• Distributor Facility Aware Date: 12/22/2017
• Device Age: 3 YR
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other