MAUDE Adverse Event Report: GREATBATCH MEDICAL SA OFFSET CUP IMPACTOR

Model Number OR71368569

Device Problems Device Issue (2379); Device Dislodged or Dislocated (2923)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/22/2011

Event Type  Injury  

Event Description

Customer reports on (b)(6) 2014; during an unknown procedure the pins in the universal joint of the offset shell impactor became dislodged during shell impaction.The surgeon was unable to unscrew the impactor from the impacted shell.Customer states there was a delay in surgery of greater than 30 minutes.No add'l info was provided on patient outcome.Patient age and gender are unknown.

Manufacturer Narrative

Investigation is currently in process.Once completed a f/u medwatch 3500a will be submitted.

Manufacturer Narrative

The complaint sample was not returned to (b)(4) for evaluation and the reported event cannot be confirmed.A process review was completed and no discrepancies were found.The initial investigation completed by the distributor stated there was no investigation needed as the product was made to specification.The root cause of the malfunction in this complaint was attributed to user error.No further investigation is required.Complaint sample not returned to the manufacturer (b)(4).

Manufacturer Narrative

(b)(4) is not the legal manufacturer of the device involved in this incident.

• Brand Name: OFFSET CUP IMPACTOR
• Type of Device: OFFSET CUP IMPACTOR
• Manufacturer (Section D): GREATBATCH MEDICAL SA; l' echelette 7; orvin CH-25 34; SZ CH-2534
• Manufacturer (Section G): GREATBATCH MEDICAL SA; l'echelette 7; ch-2534; orvin, ; SZ
• Manufacturer Contact: noe rivera ; 4545 kroemer road; fort wayne, IN 46818 ; 2607557490
• MDR Report Key: 3908239
• MDR Text Key: 20697297
• Report Number: 9614497-2014-00064
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor,company representati
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OR71368569
• Device Catalogue Number: T12083
• Device Lot Number: 10LM10033
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention