MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS

Catalog Number 221750041

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The surgeon made a complaint about the impactor during the case.The ratcheting mechanism that allows rotation of the handle relative to the tip is playing up and not allowing movement after impaction.This prevents adjustment during surgery right when its needed.Was surgery delayed due to the reported event? no, was procedure successfully completed? yes, were fragments generated? no, patient status/outcome/consequences: no, revision) required: no.

Event Description

As for the ratcheting handle 'playing up', i couldn't get my hands on it to be able to describe it accurately but from what the surgeon was saying: the button that disengages the rotating hand piece from the shaft was sticking and not disengaging.The surgeon had to get quite forceful with it to get it to move.The day i saw this was apparently the 3rd or 4th time the surgeon had mentioned this and he was getting frustrated with it.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary
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> no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).Based on the inability to find any additional related reports against the provided product code/lot code combination(s) it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN STRAIGHT CUP IMPACTOR
• Type of Device: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8667904
• MDR Text Key: 146966519
• Report Number: 1818910-2019-95205
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295098980
• UDI-Public: 10603295098980
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2019

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 Catalogue Number: 221750041
• Device Lot Number: NT1209
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 05/23/2019; 07/22/2019
• Supplement Dates FDA Received: 06/10/2019; 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1