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

Catalog Number 2102-0410

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

When reaming the acetabulum, the rotation of the reamer was shaking.Connection between the attachment and the distal part of the reamer handle was unstable.

Manufacturer Narrative

Correction: type of reportable event to malfunction.An event regarding assembly issue involving an acetabular reamer handle was reported.The event was not confirmed.Method & results: -device evaluation and results: the returned device is a source controlled device; evaluation was performed by the supplier, (b)(4).The supplier indicated, "the ¿rotation of the reamer was shaking¿ could not be recreated.Additionally, a reamer attachment simulator was used to check the reamer attachment coupling.No issues were observed.A power adaptor simulator was used to check connection with the power adaptor.No issues were observed.The complaint sample many signs of wear in the form of scratches, nicks and gouges throughout.The returned complaint sample was etched per applicable drawings." -medical records received and evaluation: not performed since no patient involvement was reported.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the investigation could not be confirmed as no failure was detected on the complaint sample.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

When reaming the acetabulum, the rotation of the reamer was shaking.Connection between the attachment and the distal part of the reamer handle was unstable.

• Brand Name: ACETABULAR REAMER HANDLE
• 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: 6876440
• MDR Text Key: 86620756
• Report Number: 0002249697-2017-02827
• 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: 01/17/2018

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 Catalogue Number: 2102-0410
• Device Lot Number: V37229001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other