MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACETABULAR REAMER 57MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2102-0457

Device Problems Device Handling Problem (3265); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Primary procedure, hip.It was reported that while reaming, the crossbars of the 57mm reamer sheared off and disassociated from the reamer basket.All pieces removed from patient and verified by visual inspection, irrigation, and suction.There was no surgical delay as the reaming for that size was completed and the next size up was reamed as planned.Surgery completed successfully with no patient harm.Rep reported that x-rays, medical records, and additional information are not available.

Manufacturer Narrative

An event regarding crack/fracture involving a cutting edge reamer was reported.The event was confirmed based on the evaluation of the returned device.Method & results: device evaluation and results: the returned device is a source controlled device.Evaluation was performed by the supplier, greatbatch medical, and indicated: the complaint sample was returned to viant for evaluation and the reported event was confirmed.The complaint sample was returned to integer for evaluation and the reported event was confirmed.The reamer was returned in two (2) pieces as the crossbar on the reamer had fractured at all four (4) welds where it is secured to the hemispherical reamer head.The broken crossbar also had gouges/indentations on them.Some of the cutting teeth on the reamer were dull and had nicks and gouges out of them.There were scratches and nicks throughout the surface of the reamer as well.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the complaint sample was returned to viant for evaluation and the reported event was confirmed.The complaint sample was returned to integer for evaluation and the reported event was confirmed.The reamer was returned in two (2) pieces as the crossbar on the reamer had fractured at all four (4) welds where it is secured to the hemispherical reamer head.The broken crossbar also had gouges/indentations on them.Some of the cutting teeth on the reamer were dull and had nicks and gouges out of them.There were scratches and nicks throughout the surface of the reamer as well.Surgical instruments are susceptible to wear and tear, and therefore should be checked for defects before use.Worn reamers will become less effective over time and will require additional forces to ream correctly, causing additional stress on the welded edges of the cross bars.These additional forces can cause the observed breakage.This reamer had been in the field approximately 10 years.It is unknown as to how many surgical procedures (cycles) this reamer had gone through throughout its life in the field.Based on the wear observed and the amount of time in the field, this reamer had exceeded its expected useful life.Viant does not own regulatory responsibility for this device, however viant does own similar devices to this acetabular reamer.The viant (legacy greatbatch) risk management files were reviewed and the failure mode was identified and mitigated to the lowest possible level.Per the trend analysis, the failure rate falls well below the occurrence rate identified in the viant (legacy greatbatch) risk management files.In conclusion, the reported event is confirmed and is attributed to wear.This reamer has exceeded its expected useful life as it has signs of normal wear and tear from repeated intended use.No further investigation is required.

Event Description

Primary procedure, hip.It was reported that while reaming, the crossbars of the 57mm reamer sheared off and disassociated from the reamer basket.All pieces removed from patient and verified by visual inspection, irrigation, and suction.There was no surgical delay as the reaming for that size was completed and the next size up was reamed as planned.Surgery completed successfully with no patient harm.Rep reported that x-rays, medical records, and additional information are not available.

• Brand Name: ACETABULAR REAMER 57MM
• 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: 8357506
• MDR Text Key: 137130436
• Report Number: 0002249697-2019-01113
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K161569
• 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: 09/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 2102-0457
• Device Lot Number: V26183001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other