MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM STEREOTAXY

Catalog Number CRWPRECISE

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Unintended Movement (3026)

Patient Problems No Patient Involvement (2645); No Code Available (3191)

Event Type  malfunction  

Event Description

It was reported that during the product demo, it was noticed that there were 2 screws of a main component that were loose (one of the rings of the arc). The base of the arc moves, compromising accuracy. The device was not in contact with a patient.

Manufacturer Narrative

Integra has completed their internal investigation on 17may2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaint history. Results: evaluation of device: the two tamper-proof screws on the left trunnion assembly were found to be loose. However, there was visible evidence of tampering and improper care as supported by images of gouges in the left trunnion assembly surface. The unit was received by integra (b)(4) in the sterilization case outside of its original packaging. Several cosmetic defects were observed on all components of the device with the most significant defects noted on the left trunnion assembly (b)(4), right trunnion assembly (b)(4), trunnion support assembly (b)(4), rectangle arc (b)(4), and full arc (b)(4). Device history record reviewed for this product id lot # p1297 manufactured on october 22, 2015 show no abnormalities related to the reported failure. This device passed all required inspection points with no associated mrr¿s, variances or rework. A two year look back in complaints history for this reported failure and or related to "base of arc moves, screws loose" for this product id shows that 2 complaints were received including this case. No new design or manufacturing trends have been identified. In summary, although the end user¿s experience was confirmed, the root cause for this occurrence cannot be definitively determined. According to the customer, this was an out of box failure. However, per the applicable inspection plan, this device is subjected to 100% inspection for surface flaws, proper assembly, and functionality prior to receipt into inventory. It is also packaged in a corrugated box with foam inserts to protect it from damage during shipping and handling. It is most likely that the loose screws, observed dings, nicks, scratches and damage to the device are the result of improper care and packaging by the customer. There was visible wear and tear on the returned unit and it was received outside of its original packaging.

• Brand Name: CRW PRECISION ARC SYSTEM
• Type of Device: STEREOTAXY
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5477409
• MDR Text Key: 39847273
• Report Number: 3004608878-2016-00042
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CRWPRECISE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown