MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK COLORADO NEEDLE, 5" STRAIGHT SLEEVE, 3MM 45 ANG; INSTRUMENT

Catalog Number	E1135
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by a company representative that during incoming inspection a foreign material in the shape of a hair was found in a colorado needle package.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Additional Manufacturer Narrative
The inspection of the device provided could confirm the reported event.The manufacturer stryker instruments, (b)(4) confirmed that the size of the hairs exceeded the permitted criteria.Nc # 1037222 was already initiated for the previous complained event reporting the same failure mode (refer to pi# (b)(4)), followed by nc # 1014352 (pi # (b)(4)), for (b)(4) nc # 1189804 was initiated and pi (b)(4), as well as pi (b)(4) is addressed in nc # 1250381.The currently complained pi (b)(4) as well as 1205159 were investigated in nc # 1224122.The package returned to stryker instruments, (b)(4), will be retained to complete a device defect awareness training with the operators that did not detect the presence of the hairs in the packages when completing the inspection.There have been multiple ncs for this issue type.Therefore it was escalated and linked to capa (b)(4) - hair in packs found at distribution centre.The capa is still ongoing.Summarizing all facts the root cause can be attributed to a manufacturing (packaging) related issue.
Event or Problem Description
It was reported by a company representative that during incoming inspection a foreign material in the shape of a hair was found in a colorado needle package.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: COLORADO NEEDLE, 5" STRAIGHT SLEEVE, 3MM 45 ANG
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• MDR Report Key: 5739526
• Report Number: 0008010177-2016-00134
• Device Sequence Number: 3013
• Product Code: GEI
• UDI-Device Identifier: 04546540001238
• UDI-Public: (01)04546540001238(17)210501(10)16125017
• Combination Product (Y/N): N
• PMA/510(K) Number: K033232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2016

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: Other
• Device Catalogue Number: E1135
• Device Lot Number: 16125017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2016
• Supplement Report FDA Received Date: 12/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1