MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2101-0200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Have received a 2101-0200 from customer.They don¿t know when product broke.Discovered in sterile department.It¿s been forgotten in a box.Has not been used in surgery since discovered damage.
Additional Manufacturer Narrative
An event regarding thread damage involving a cutting edge impactor was reported.Review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.There have been no other events for the lot referenced.Conclusion: the reported event for damage was confirmed.A material analysis inspection was performed and indicated "fracture observed on tip of threads consistent with an overload condition and contact against a hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." the device was discovered during inspection.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.
Event or Problem Description
Have received a 2101-0200 from customer.They dont know when product broke.Discovered in sterile department.It¿s been forgotten in a box.Has not been used in surgery since discovered damage.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8372143
• Report Number: 0002249697-2019-01191
• Device Sequence Number: 1203940
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2010
• Device Catalogue Number: 2101-0200
• Device Lot Number: BZMAF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other