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U.S. Department of Health and Human Services

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

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INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM STEREOTAXY Back to Search Results
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.
 
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Brand NameCRW PRECISION ARC SYSTEM
Type of DeviceSTEREOTAXY
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 Key5477409
MDR Text Key39847273
Report Number3004608878-2016-00042
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K944463
Number of Events Reported1
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 Received03/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberCRWPRECISE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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