MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER MIS H/COLLAR SEALS 5-PK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 09373225

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.A supplemental report will be submitted upon completion of the investigation.

Event Description

On opening packaging of exeter "horse collar" femoral cement seal, the scrub nurse noticed a thin piece of the plastic foam was detached.It appeared to be a clean cut.Outside packaging was intact.This item was discarded and not used.

Manufacturer Narrative

Additional info: tab d- lot number an event regarding damage to an exeter horse collar was reported.The damage was confirmed through the return of the device.Conclusion: the reported event was reviewed by the supplier bemis.Final response was received from the supplier 27 june2018.They had reviewed their batch records, and no evidence of unusual process was found.Their stock on hand was inspected, and no defective product was found.The supplier stated that this defect had never been observed before, but they established a shortlist of the most likely causes, and attempts were made to reproduce the effect.A definitive root cause could not be determined as these attempts were unsuccessful.However, the most probable cause of the defect was defined as being a result of a vent channel being blocked during the manufacturing process.The assessment was that this was an isolated occurrence, a singular defect that would not have affected the entire batch.As part of a corrective plan, additional cleaning controls have been implemented and the visual inspection for this defect has been incorporated into the production process inspection routine.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

On opening packaging of exeter "horse collar" femoral cement seal, the scrub nurse noticed a thin piece of the plastic foam was detached.It appeared to be a clean cut.Outside packaging was intact.This item was discarded and not used.

• Brand Name: EXETER MIS H/COLLAR SEALS 5-PK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7483771
• MDR Text Key: 107276310
• Report Number: 0002249697-2018-01331
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Catalogue Number: 09373225
• Device Lot Number: LRP3882A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other