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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device expander, surgical, skin graft
Regulation Description Manual surgical instrument for general use.
Product CodeFZW
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 486 486
2021 554 554
2022 510 510
2023 606 606
2024 443 443
2025 206 206

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1343 1343
Material Twisted/Bent 607 607
Physical Resistance/Sticking 486 486
Appropriate Term/Code Not Available 186 186
Material Deformation 98 98
Naturally Worn 81 81
Patient Device Interaction Problem 62 62
Mechanical Problem 59 59
Break 55 55
Mechanical Jam 48 48
Insufficient Information 48 48
Fitting Problem 47 47
Calibration Problem 35 35
Material Integrity Problem 31 31
Component Missing 28 28
Dull, Blunt 25 25
Difficult to Remove 25 25
Delivered as Unsterile Product 20 20
Failure to Advance 16 16
Positioning Problem 15 15
Activation, Positioning or Separation Problem 12 12
Retraction Problem 12 12
Loose or Intermittent Connection 11 11
Output Problem 11 11
Activation Failure 11 11
No Apparent Adverse Event 9 9
Detachment of Device or Device Component 9 9
Difficult to Open or Close 7 7
Material Discolored 7 7
Activation Problem 6 6
Device Slipped 5 5
Device Markings/Labelling Problem 5 5
Connection Problem 5 5
Difficult to Advance 5 5
Defective Device 5 5
Misassembled 5 5
Degraded 5 5
Failure to Align 5 5
Electrical /Electronic Property Problem 4 4
Dent in Material 4 4
Material Too Rigid or Stiff 4 4
Noise, Audible 3 3
Failure to Disconnect 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Packaging Problem 3 3
Positioning Failure 2 2
Unstable 2 2
Structural Problem 2 2
Material Split, Cut or Torn 2 2
Flaked 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2168 2168
No Patient Involvement 305 305
No Consequences Or Impact To Patient 207 207
Insufficient Information 92 92
No Known Impact Or Consequence To Patient 71 71
Laceration(s) 43 43
Abrasion 38 38
Skin Tears 16 16
No Code Available 2 2
Unspecified Tissue Injury 2 2
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Surgical Inc II Feb-13-2024
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