MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA TITANIUM RETRACTOR ARM ASSY-9 INCHES; RETRACTOR SYSTEM COMPONENTS

Catalog Number	443A1070A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
When the surgeon was going to place one of the 443a1070a titanium retractor flexible arms to the halo ring, the support of the arm broke and got separated from the arm.He then tried to place the other two (2) arms and the same exactly thing happened.The patient was prepped for surgery and the incident led to a delay in surgery by 2 hours.There was no patient injury reported and the device was not yet in contact with the patient.
Additional Manufacturer Narrative
Integra has completed their internal investigation on 02/15/2017.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: engineering was able to confirm the customer complaint on the retractor arms breaking device history record reviewed for this product id lot #139 manufactured on december 31, 2013 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.A two year lookback in (b)(6) for this reported failure and or related to "broke and get separate from the arm" for this product id shows that no additional complaints were received.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: in summary: engineering was able to verify the customer complaint.The root cause may be attributed to over tightening the knob during procedure.No other similar complaints were observed.Thus, this issue will be monitored for trending.

• Brand Name: TITANIUM RETRACTOR ARM ASSY-9 INCHES
• Common Device Name: RETRACTOR SYSTEM COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 6234335
• Report Number: 3004608878-2017-00010
• Device Sequence Number: 1100042
• Product Code: GZT
• Combination Product (Y/N): N
• PMA/510(K) Number: K830332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 443A1070A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1