MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. LONG EXTRACTION ADAPTOR 3/8 - 16 UNC - M5; ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE

Catalog Number A47L38M5

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that 55 products long extractor adaptator 3/8-16, reference a47l38m5, batch 0909464010 were manufactured on 10th october 2013.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that during the revision procedure of stem due to pain, the gts extractor got broken while the surgeon was extracting the stem.Another extractor was used during the surgery.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device was not returned to the manufacturer.Therefore it could not be analyzed.A picture of the product has been received and it was noticed thaht the extractor adaptor did not seems broken.Indeed, it is possible that the thread was broken, however, it is impossible to verify with the picture provided.Therefore, the reported event could not be confirmed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The review of the raw material certificate could not be performed as the document was not available.Within one year, only the current complaint has been recorded regarding a fracture on long extraction adaptor 3/8 - 16 unc - m5, reference a47l38m5, batch 0909464010.According to available data, root cause of the event was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during the revision procedure of stem due to pain, the gts extractor got broken while the surgeon was extracting the stem.Another extractor was used during the surgery.No adverse events have been reported as a result of the malfunction.

• Brand Name: LONG EXTRACTION ADAPTOR 3/8 - 16 UNC - M5
• Type of Device: ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 9509284
• MDR Text Key: 217435273
• Report Number: 3006946279-2019-00550
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 03599870111932
• UDI-Public: (01)03599870111932
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

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 Catalogue Number: A47L38M5
• Device Lot Number: 0909464010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 50 YR